MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-15 for GSI SPACEMAKER DBD - 1500 * manufactured by General Surg. Innovation, Inc..
[65950]
Pt scheduled for laproscopic repair of right inguinal hernia under general anesthesia. A small abdominal incision was made and balloon dissector placed. Balloon malfunctioned and had to be cut to empty the water. The balloon dissector was then removed. Camera inspection showed that the balloon had opened the peritoneum. Laparoscopy was aborted and an open hernia repair performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 106694 |
| MDR Report Key | 106694 |
| Date Received | 1997-07-15 |
| Date of Report | 1997-06-13 |
| Date of Event | 1997-06-03 |
| Date Facility Aware | 1997-06-03 |
| Report Date | 1997-06-13 |
| Date Added to Maude | 1997-07-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GSI SPACEMAKER |
| Generic Name | SURGICAL BALLOON DISSECTOR/CANNULA |
| Product Code | GCC |
| Date Received | 1997-07-15 |
| Model Number | DBD - 1500 |
| Catalog Number | * |
| Lot Number | G6C06 |
| ID Number | 1500CC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 104876 |
| Manufacturer | GENERAL SURG. INNOVATION, INC. |
| Manufacturer Address | * PALO ALTO CA 94304 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-07-15 |