—#73786

Product

26" Vision Elect HDTV Surgical Viewing Monitor, model number 0240030960, Manufactured by Stryker Endoscopy San Jose Intended to be used as a visualization device for events occurring in the sterile field for endoscopic surgical procedures.

FDA product code: GCJ — Laparoscope, General & Plastic Surgery
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K935234
Affected lot / code info: PER Number(s): 98131, 99085,101141,105591,101235,101212, 109617, 110104, 110852,110974,111006,111048,111081,111105, 111181, 111199, 111202, 111303, 111492, 111562, 111595, 111868, 111912, and 111935

Why it was recalled

Knob parts stick together, resulting in poor functionality of the knob.

Root cause (FDA determination)

Device Design

Action the firm took

Urgent: Device Correction letters dated 9/22/2008 were sent to Sales representatives and all accounts. Sales reps were also notified via email. Each Sales Rep was provided rework instructions, a list of affected accounts and serial numbers, and new knobs to install on affected units. Customers were asked to inspect their inventory for the part number, they were informed that their sales rep would be responsible for replacing the rotary knobs on all affected units, and that they should contact their sales rep to schedule the knob replacement.

Recalling firm

Firm: Stryker Endoscopy
Address: 5900 Optical Ct, San Jose, California 95138

Distribution

Distribution pattern: Worldwide Distribution --- USA including states of Alabama, Arkansas, Arizona, California, Colorado, Connecticut, DC, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, and Wyoming, and countries of Australia, Canada, China, England, France, Germany, Greece, Iberia, India, Israel, Japan, Korea, Mexico, Netherlands, Poland, Portugal, Scandinavia, Singapore, South Africa, Switzerland, and Taiwan.

Timeline

Recall initiated: 2008-09-22
Posted by FDA: 2008-10-24
Terminated: 2010-12-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73786. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.