SURG PAT XRAY 1/2X1/2
Received May 8, 2013 · Event occurred Apr 18, 2013
Report 1226348-2013-16737 · MDR key 3099549
Device
Generic name
Surgical Sponge
Manufacturer
Codman & Shurtleff, Inc.Catalog number
80-1400
Lot number
184407
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
THE REP REPORTED THAT THE PATTIE WAS MISPLACED DURING THE SURGERY, HOWEVER, WHEN LOCATED THE DEVICE WAS X-RAYED AND COULD NOT BE SEEN UNDER XRAY. IN ADDITION A DEVICE FROM ANOTHER LOT, NOT USED IN THE CASE WAS ALSO XRAYED AND COULD NOT BE SEEN.
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. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS HAVE BEEN CONDUCTED AND THEY REVEALED THAT THE DEVICE CONFORMED TO ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO BEING RELEASED TO STOCK. IF AT SOME POINT THE DEVICE IS RETURNED FOR EVALUATION THIS COMPLAINT WILL BE RE-OPENED AND INVESTIGATED. BASED ON THIS EVALUATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED. PLEASE NOTE THAT A THERAPY DATE HAS BEEN SPECIFIED AS IT IS A REQUIRED FIELD. WE DO NOT USE THERAPY DATES AND AS A RESULT TODAY'S DATE WAS USED. (B)(4): DEVICE NOT RETURNED.