ADSON DISSECTING HOOK
Received Sep 9, 2011
Report 1226348-2011-00340 · MDR key 2241697
Device
Generic name
Hook, Surgical, Genl Plastic Surgery
Manufacturer
Codman And Shurtleff - New BedfordCatalog number
38-1061
Lot number
9803N
Product problems
- Break
- Other (for use when an appropriate device code cannot be identified)
Patient
Not reported
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE INSTRUMENT WAS BEING USED IN THE INTENDED FASHION. EXCESSIVE FORCE WAS NOT APPLIED THAT WOULD HAVE CAUSED THE DEVICE TO BREAK. SURGEON KNEW IMMEDIATELY THAT THE INSTRUMENT BROKE, AND TRIED TO LOCATE AND RETRIEVE THE REMNANT, BUT CONCLUDED THAT IT WAS TOO CLOSE TO THE SPINAL CORD TO TRY TO REMOVE.
Additional Manufacturer Narrative
IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IT SHOULD BE NOTED THAT THIS DEVICE IS MORE THAN 13 YEARS OLD. IF AT SOME POINT THE DEVICE DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT AVAILABLE.
Additional Manufacturer Narrative
AS NOTED IN THE INITIAL REPORT THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. IN THE ABSENCE OF THE PRODUCT SINCE A LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WAS CONDUCTED AND CONFIRMED THAT THIS DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTION. IT WAS ALSO NOTED THAT THIS IS THE FIRST COMPLAINT REPORTED FOR THIS LOT NUMBER AND THEREFORE IS CONSIDERED TO BE AN ISOLATED EVENT. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED. DEVICE WAS NOT RETURNED.