MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2007-01-05 for LAPSAC 054800 manufactured by Cook Urological, Inc..
[15096676]
"on (b)(6) 2006, a pt was injured during a laparoscopic splenectomy. Two devices were utilized during the course of the surgery; namely, a gynecare x-tract tissue morcellator and a cook urological, inc. Lapsac surgical tissue pouch. It would appear from our preliminary investigation that the tissue morcellator penetrated the bag and injured this pt's aorta, vena cava and bowel. Specifically, the cook bag used during the surgery was the 8x10 pouch, order no. (b)(4), lot. No. U1551052. "
Patient Sequence No: 1, Text Type: D, B5
[15276820]
A proper eval cannot be performed at this time, due to the product not being returned. Currently working through the attorney to determine a date to view the product at the hospital. At the present time, there has not been an indication of the failure mode and nothing stating which if either device failed. Products from internal stock was pulled and evaluated ensuring seals are intact noting the products to be within specification. Nothing was viewed that could have potentially caused this type of incident. As info becomes available, it will be promptly forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825146-2006-00029 |
| MDR Report Key | 2920584 |
| Report Source | 00,07 |
| Date Received | 2007-01-05 |
| Date of Event | 2006-10-27 |
| Date Facility Aware | 2006-10-27 |
| Date Mfgr Received | 2006-11-10 |
| Device Manufacturer Date | 2006-07-01 |
| Date Added to Maude | 2013-01-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | TAMMY BACON |
| Manufacturer Street | 1100 WEST MORGAN ST. |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal | 47460 |
| Manufacturer Phone | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LAPSAC |
| Generic Name | SURGICAL TISSUE POUCH |
| Product Code | KGY |
| Date Received | 2007-01-05 |
| Catalog Number | 054800 |
| Lot Number | U1551052 |
| Device Expiration Date | 2009-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK UROLOGICAL, INC. |
| Manufacturer Address | SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2007-01-05 |