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 2016-08-15 for MIC1332 manufactured by Sterilmed, Inc..
[52095741]
The device has not yet been returned to the manufacturer at the time of this report. A supplemental form will be sent once the evaluation is completed if the device is returned. The device history report was reviewed and no discrepancies were found.
Patient Sequence No: 1, Text Type: N, H10
[52095742]
It was reported that the jaws were broken when trying to biopsy tissue from the patient. No patient harm or consequences was reported. Additional information was requested, but there was no additional information available.
Patient Sequence No: 1, Text Type: D, B5
[54041978]
The biopsy forceps was returned to the manufacturer with its jaws damaged but functional. A portion of the opening and closing mechanism is out of position and clearly sticks out from the jaws. The damage is obvious to the naked eye and the device would not be shipped in this condition. According to the account, the device became damaged when it was used in the field. The root cause for the damage remains unknown, though the device may have been damaged during its handling or use in the field.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2016-00056 |
| MDR Report Key | 5875363 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-08-15 |
| Date of Report | 2016-09-05 |
| Date Mfgr Received | 2016-09-05 |
| Device Manufacturer Date | 2016-04-18 |
| Date Added to Maude | 2016-08-15 |
| 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 PARKWAY 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 | 2016-08-15 |
| Returned To Mfg | 2016-09-05 |
| Model Number | MIC1332 |
| Catalog Number | MIC1332 |
| Lot Number | 1941169 |
| Device Expiration Date | 2017-04-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2016-08-15 |