MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-07 for LAPAROSCOPIC CHOLECYSTECTOMY KIT LSRHHLAPCHC manufactured by Leesar, Inc..
[32768045]
Patient Sequence No: 1, Text Type: N, H10
[32768046]
Over a period of time, our operating room staff have identified incorrect sponge counts right out of the package. We have been reporting them via medsun. Our custom surgical pack operations company asked for a meeting regarding our problems with sponge counts and we did so this month. They explained quite in detail what they have been doing for the last few months to mitigate this problem. In summary, our vendor puts together the packs, opens the sponge packs received from the manufacturer and counts twice on their assembly line. One person counts, then it goes to the next person to count. Our operating room staff educators have shared this with our staff; our counts are done by laying out the sponges separately on a flat surface. At this time, we are seeing fewer incidences of incorrect numbers of sponges in packs and we hope the problems have been resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5270146 |
| MDR Report Key | 5270146 |
| Date Received | 2015-12-07 |
| Date of Report | 2015-11-19 |
| Date of Event | 2015-09-01 |
| Report Date | 2015-11-19 |
| Date Reported to FDA | 2015-11-19 |
| Date Reported to Mfgr | 2015-11-19 |
| Date Added to Maude | 2015-12-07 |
| 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 | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LAPAROSCOPIC CHOLECYSTECTOMY KIT |
| Generic Name | LAPAROSCOPIC CHOLECYSTECTOMY KIT |
| Product Code | PKE |
| Date Received | 2015-12-07 |
| Model Number | LSRHHLAPCHC |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEESAR, INC. |
| Manufacturer Address | 2727 WINKLER AVENUE FORT MYERS FL 33901 US 33901 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-07 |