MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-24 for INSULCAN 9400-02 * manufactured by Mobile Instrument Service And Repair, Inc.
[15322344]
These devices are to check the insulation on laparoscopic instruments. Five (5) have failed in the last two weeks. The wiring inside the device coming from the power connector (12 volt dc)to the pc board and battery have melted and burned. ======================manufacturer response for insulation tester, insulcan (per site reporter). ======================none yet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4154843 |
| MDR Report Key | 4154843 |
| Date Received | 2014-09-24 |
| Date of Report | 2014-09-24 |
| Date of Event | 2014-09-22 |
| Report Date | 2014-09-24 |
| Date Reported to FDA | 2014-09-24 |
| Date Reported to Mfgr | 2014-10-09 |
| Date Added to Maude | 2014-10-09 |
| 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 |
| 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 | INSULCAN |
| Generic Name | COAGULATOR, LAPAROSCOPIC, AND ACCESSORIES |
| Product Code | HFG |
| Date Received | 2014-09-24 |
| Model Number | 9400-02 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MOBILE INSTRUMENT SERVICE AND REPAIR, INC |
| Manufacturer Address | 333 WATER AVE BELLEFOUNTAINE OH 43311 US 43311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-09-24 |