D
Patient 1
COMPLAINANT ALLEGES THAT DURING A LAPAROSCOPIC GYNECOLOGICAL PROCEDURE, THE JAW OF THE NEEDLE HOLDER BROKE AND A PORTION OF IT REMAINED IN THE ABDOMEN OF THE PT.
MAUDE MDR 245197
- MDR report key
- 245197
- Report number
- 1038548-1999-00038
- Event key
- 0
- Event type
- 3
- Date of event
- 1999-09-14
- Date received
- 1999-10-15
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MR PETER STEGAGNO, DIRECTOR, QA/RA
- Address
- 5175 S. ROYAL ATLANTA DR TUCKER GA 30084 US
- Phone
- 770-770-7707
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MCKERNAN DIAMOND-JAW NEEDLE HOLDER | ENDOSCOPIC INSTRUMENT | GENZYME SURGICAL PRODUCTS | GCJ | * | 90-7002 | L98 | K960400 | N | Y | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 1999-10-15 | 0 | 1. O |