FDA Adverse Event
Injury
Summary report: N
SPACEMAKER I
MDR report key: 168894
·
Received May 21, 1998
Report
- Report Number
- 2951239-1998-00001
- Event Type
- Injury
- Date Received
- May 21, 1998
- Manufacturer
- GENERAL SURGICAL INNOVATIONS
- Product Code
- GCJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
BLADDER WAS PERFORATED DURING LAPAROSCOPIC HERNIA REPAIR. THE BALLOON DISSECTOR WAS INFLATED AND APPEARED TO FUNCTION PROPERLY. THE BALLOON DID NOT APPEAR TO MALFUNCTION. A TROCAR (NOT GSI TROCAR) WAS INSERTED; VIA ENDOSCOPE, A TEAR IN THE BLADDER WAS OBSERVED. ENDOSCOPIC REPAIR OF THE BLADDER WAS NOT SUCCESSFUL; PROCEDURE CONVERTED TO OPEN. BLADDER TEAR WAS REPAIRED VIA OPEN SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPACEMAKER I | BALLOON DISSECTOR | GCJ | GENERAL SURGICAL INNOVATIONS | 900CC | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |