MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-05-14 for T DISSECTOR "L" HOOK 28775UF manufactured by Karl Storz Endoscopy-america, Inc..
[15442948]
Instrument tip "l" hook broke off inside pt during laparoscopic procedure; x-ray verified tip inside pt; re-opened pt to remove tip. Mfg date code, kp = 10/95 (in warranty). Procedure required approx 5 hrs to conduct, including retrieval of foreign body. Post-op recovery uneventful to this point. Causation of fbo undetermined at present.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 33748 |
| MDR Report Key | 33748 |
| Date Received | 1996-05-14 |
| Date of Report | 1996-05-13 |
| Date of Event | 1996-05-08 |
| Date Facility Aware | 1996-05-08 |
| Report Date | 1996-05-14 |
| Date Reported to FDA | 1996-05-14 |
| Date Reported to Mfgr | 1996-05-14 |
| Date Added to Maude | 1996-07-01 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | T DISSECTOR "L" HOOK |
| Generic Name | T DISSECTOR "L" HOOK |
| Product Code | FHB |
| Date Received | 1996-05-14 |
| Model Number | 28775UF |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 7 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 35098 |
| Manufacturer | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Manufacturer Address | 600 CORPORATE POINT CULVER CITY CA 902307600 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-05-14 |