MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-30 for ENDOPOUCH RETRIEVER * manufactured by Ethicon Endo-surgery, Inc..
[19495092]
A patient was undergoing a laparoscopic cholecystectomy. An endopouch specimen retrieval bag was introduced through the upper 10 mm port site and the gallbladder was placed in it. Because the gallbladder was friable and thick-walled the surgeon enlarged the upper incision and in the process of manipulating the gallbladder and its contents up into the wound, the bag broke (with little stress), releasing the stone. The gallbladder was easily retributred, but the surgeon could not find the large stone that was within it. The surgeon, therefore, enlarged the incision, incised fascia and divided muscle in the right portion of the incision partially so there was about a 4 inch laparotomy incision. With that, the surgeon was able to find the liberated stone in the subhepatic area and remove it. The surgeon was satisfied there was no bleeding or other problems and the remainder of the procedure was without complications. Ethicon was notified of the occurrence and a representative came to the facility to pick up the specimen retrieval bag.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 599350 |
| MDR Report Key | 599350 |
| Date Received | 2005-03-30 |
| Date of Report | 2005-03-30 |
| Date of Event | 2005-03-17 |
| Report Date | 2005-03-30 |
| Date Reported to FDA | 2005-03-30 |
| Date Added to Maude | 2005-05-06 |
| 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 | ENDOPOUCH RETRIEVER |
| Generic Name | SPECIMEN RETRIEVAL BAG |
| Product Code | FEQ |
| Date Received | 2005-03-30 |
| Returned To Mfg | 2005-03-20 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | CE0123 V43H55 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 589177 |
| Manufacturer | ETHICON ENDO-SURGERY, INC. |
| Manufacturer Address | 4545 CREEK ROAD CINCINNATI OH 45242 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-03-30 |