MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-18 for ETHICON ENDOPATH 512 X AND 512S TROCARS 512X 512S manufactured by Ethicon Endo-surgery.
[18933]
During elective laparoscopic procedure. Laceration to small bowel and right iliac artery & vein resulted following puncture by trocar. Patient incurred large volome of blood loss requiring multiple transfusions; required emergency laparotomy and repair and grafting of rt. Iliac artery/vein, repair of small bowel tear; cystoscopy; insertion of r ureteral stent. Note: as of this date, there is no determination of actual cause, i. E. , user error vs equipment failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 26445 |
| MDR Report Key | 26445 |
| Date Received | 1995-01-18 |
| Date of Report | 1994-10-05 |
| Date of Event | 1994-09-29 |
| Date Facility Aware | 1994-09-29 |
| Report Date | 1994-10-05 |
| Date Reported to Mfgr | 1994-10-05 |
| Date Added to Maude | 1995-10-04 |
| 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 | ETHICON ENDOPATH 512 X AND 512S TROCARS |
| Generic Name | DISPOSABLE 10/12 TROCARS |
| Product Code | FBQ |
| Date Received | 1995-01-18 |
| Model Number | 512X 512S |
| Lot Number | GB5008 GG4747 |
| Device Expiration Date | 1999-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 27135 |
| Manufacturer | ETHICON ENDO-SURGERY |
| Manufacturer Address | 4545 CREEK ROAD CINCINNATI OH * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit | 1995-01-18 |