MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-03 for COOCTI-512N manufactured by Sterilmed, Inc..
[81690744]
Patient Sequence No: 1, Text Type: N, H10
[81690745]
During a laparoscopic appendectomy procedure, the surgeon attempted to deploy a wound closure device when the device failed in his hand. The closure rod separated from the opening handle assembly. Fascia closure system replaced with new device and defective device set to biomedical for reporting. Surgery completed with no additional incidents.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6763111 |
| MDR Report Key | 6763111 |
| Date Received | 2017-08-03 |
| Date of Report | 2017-07-26 |
| Date of Event | 2017-07-24 |
| Report Date | 2017-07-26 |
| Date Reported to FDA | 2017-07-26 |
| Date Reported to Mfgr | 2017-07-26 |
| Date Added to Maude | 2017-08-03 |
| 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 | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | NA |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED - REPROCESSED CLOSURE SYSTE |
| Product Code | NLM |
| Date Received | 2017-08-03 |
| Model Number | COOCTI-512N |
| Catalog Number | COOCTI-512N |
| Lot Number | 1992214 |
| ID Number | CARTER-THOMASON CLOSESURE SYS |
| Device Expiration Date | 2018-04-12 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 11400 73RD AVE N STE 100 MAPLE GROVE MN 55369 US 55369 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-03 |