MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-06-29 for MIC1332 manufactured by Sterilmed, Inc..
[48414653]
The device was returned to the manufacturer. It can be confirmed that a part of the device was sticking out the side of the jaws. It appears that somehow this moving part became detached from inside the jaw mechanism. The function of this part is to hold and balance the two sides of the jaws while opening and closing the jaws. Unable to determine the root cause for this issue since the device had been used. The damage may have occurred during use. The device history report was reviewed and no discrepancies were found.
Patient Sequence No: 1, Text Type: N, H10
[48414654]
It was reported that the device broke during procedure use inside the patient. When the forceps were opened to obtain the biopsy, it broke. It was immediately removed from the patient and a new biopsy forceps were used. Nothing was left in the patient and all pieces were accounted for. There was no patient injury or consequences reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2016-00046 |
| MDR Report Key | 5757988 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-06-29 |
| Date of Report | 2016-06-16 |
| Date of Event | 2016-06-15 |
| Date Mfgr Received | 2016-06-13 |
| Device Manufacturer Date | 2016-03-09 |
| Date Added to Maude | 2016-06-29 |
| 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 | JASON ANDERSON |
| Manufacturer Street | 5010 CHESHIRE PARWAY SUITE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal | 55446 |
| Manufacturer Phone | 7634888348 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | FORCEPS, BIOPSY, NON-ELECTRIC, REPROCESSED |
| Product Code | NON |
| Date Received | 2016-06-29 |
| Returned To Mfg | 2016-06-16 |
| Model Number | MIC1332 |
| Catalog Number | MIC1332 |
| Lot Number | 1933875 |
| Device Expiration Date | 2017-03-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 11400 73RD AVE N MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-29 |