MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07,08 report with the FDA on 2011-10-14 for LAPSAC TISSUE ENTRAPMENT POUCH J-LS-060401 manufactured by Cook Urological Inc.
[19531214]
On (b)(6) 2011, customer attempted to use the lapsac tissue entrapment pouch. During use, the sac tore releasing the contents. Surgery was delayed but there was no apparent harm to the pt noted at the time of the occurrence.
Patient Sequence No: 1, Text Type: D, B5
[19751116]
One package containing a used lapsac (surgical tissue pouch) was received from the hospital. The lapsac has been ripped horizontally to the outer edges on one side of the pouch, approx 3cm from the bottom of the bag. The opposite side of the lapsac was ripped about half way across the pouch with a 1. 5cm section not torn noting the remaining section out to the edge of the pouch to be torn, also approx 3cm from the bottom of the pouch. In addition there were two vertical tears, both approx 2cm long, one of the vertical tears was l shape with a small portion of the material split and folded over on the outside of the pouch. One area of the lapsac has what appears to be a puncture with the material pushed outward in line with the ripped areas. This device has most likely been punctured by an instrument of undetermined origin. Two stock lapsacs were acquired to attempt to recreate the customers difficulty. Excessive pressure was applied to one side of the pouch noting no tearing occurred. Secondly, using a needle to puncture the center of one side of the pouch, then applied pressure to the puncture area with no tearing occurring. Excessive pressure was applied to the puncture area noting the pouch had torn as the used pouch returned. Additional info being requested without response at this time, should info become available, it will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825146-2011-00042 |
| MDR Report Key | 2301731 |
| Report Source | 01,06,07,08 |
| Date Received | 2011-10-14 |
| Date of Report | 2011-09-16 |
| Date of Event | 2011-08-10 |
| Report Date | 2011-09-16 |
| Date Mfgr Received | 2011-09-16 |
| Device Manufacturer Date | 2011-05-11 |
| Date Added to Maude | 2011-10-21 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRIS KILANDER |
| Manufacturer Street | 1100 W. MORGAN |
| 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 TISSUE ENTRAPMENT POUCH |
| Generic Name | KGY BAG, INTESTINE |
| Product Code | KGY |
| Date Received | 2011-10-14 |
| Returned To Mfg | 2011-09-28 |
| Model Number | NA |
| Catalog Number | J-LS-060401 |
| Lot Number | U2064600 |
| Device Expiration Date | 2014-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2011-10-14 |