MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-17 for STORZ 30873B * manufactured by Karl Storz Endoscopy.
[21963334]
Pt in major surgery for a laparoscopic cholecystectomy. Surgein using spatula to separate gall bladder from the liver bed. The end of the spatula snapped off and went into the body cavity. Fluroscopy was used to locate and retrieve broken piece. Inspection done, no other pieces missing. Approx 30-45 minutes of extra surgery and anesthesia time. The mfr was notified the same day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 77480 |
| MDR Report Key | 77480 |
| Date Received | 1997-03-17 |
| Date of Report | 1997-03-08 |
| Date of Event | 1997-02-28 |
| Date Facility Aware | 1997-02-28 |
| Report Date | 1997-03-08 |
| Date Reported to FDA | 1997-03-08 |
| Date Reported to Mfgr | 1997-03-08 |
| Date Added to Maude | 1997-03-24 |
| 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 | STORZ |
| Generic Name | ENDOSCOPIC SPATULA |
| Product Code | GAF |
| Date Received | 1997-03-17 |
| Model Number | 30873B |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 77187 |
| Manufacturer | KARL STORZ ENDOSCOPY |
| Manufacturer Address | 10111 W. JEFFERSON BLVD. CULVER CITY CA 902323578 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-03-17 |