FDA Adverse Event
Injury
Summary report: N
SUTURE PLACEMENT SYSTEM
MDR report key: 2003239
·
Received February 28, 2011
Report
- Report Number
- 3005099803-2011-00542
- Event Type
- Injury
- Date Received
- February 28, 2011
- Report Date
- February 2, 2011
- Manufacturer
- BOSTON SCIENTIFIC - MIAMI
- Product Code
- GCJ
- PMA / PMN Number
- K973415
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER OF THE DEVICE IS UNKNOWN; CONSEQUENTLY, THE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED. COMPONENT (B)(4) RELATES TO (B)(4) FOR NEEDLE DETACHMENT. THE ROOT CAUSE FOR THIS EVENT IS UNDETERMINABLE.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE "DEVICE FAILED DURING SURGERY." REPORTEDLY, THE NEEDLE WAS "LEFT IN THE PATIENT." THE SUTURE TYPE AND MANUFACTURER ARE UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUTURE PLACEMENT SYSTEM | LAPAROSCOPE, GENERAL & PLASTIC SURGERY | GCJ | BOSTON SCIENTIFIC - MIAMI | M0068311350 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |