FDA Adverse Event
Injury
Summary report: N
JARIT
MDR report key: 2306857
·
Received October 18, 2011
Report
- Report Number
- MW5022733
- Event Type
- Injury
- Date Received
- October 18, 2011
- Date of Event
- October 10, 2011
- Report Date
- October 18, 2011
- Manufacturer
- INTEGRA LIFE SCIENCES
- Product Code
- LRW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
NOTIFIED BY STERILE PROCESSING THAT A PORTION OF THE LAPAROSCOPIC SCISSOR TIP WAS MISSING WHEN THEY RECEIVED IT IN THEIR DEPT. HAD BEEN USED FOR LAPAROSCOPIC APPENDECTOMY PERFORMED ON AMBULATORY SURGICAL PT. PT HAD NOT YET BEEN DISMISSED. SURGEON NOTIFIED IMMEDIATELY AND X-RAY OBTAINED IDENTIFYING OBJECT REMAINED INTRA-ABDOMINALLY. PT WAS INFORMED BY THE SURGEON. DISCUSSION REGARDING WHETHER TO TRY AND RETRIEVE. TIP IS SMALL AND WOULD BE EXTREMELY DIFFICULT TO RETRIEVE, ABDOMEN DISTENDED FROM SURGERY. PT AGREES TO NOT RETURN TO SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JARIT | ROTO-CAM SUPERSCS MONO | LRW | INTEGRA LIFE SCIENCES | 5MM32CM | UNSURE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Other |