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 2016-10-19 for MIC1332 manufactured by Sterilmed, Inc..
[57871166]
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
[57871167]
It was reported that the device was tested by opening and closing prior to placing it in the scope. Upon opening, while in the patient to retrieve a biopsy, the device broke. It was noted that no fragments or pieces were left in the patient. It was reported that there was no harm detected to the patient.
Patient Sequence No: 1, Text Type: D, B5
[60537616]
The biopsy forceps were returned with a clearly damaged jaw, and a portion of the mechanism that opens and closes the jaw was out of position. The device was examined and contaminants consistent with exposure, if not use, were found to be present. The device was able to open and close without issue. The root cause for the damage was undetermined, however, as the device was used in the field, the device may have been mishandled or damaged during its use
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2016-00074 |
| MDR Report Key | 6041356 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-10-19 |
| Date of Report | 2016-09-22 |
| Date of Event | 2016-08-12 |
| Date Mfgr Received | 2016-11-18 |
| Device Manufacturer Date | 2016-04-26 |
| Date Added to Maude | 2016-10-19 |
| 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 | 2016-10-19 |
| Returned To Mfg | 2016-11-18 |
| Model Number | MIC1332 |
| Catalog Number | MIC1332 |
| Lot Number | 1942933 |
| Device Expiration Date | 2017-04-26 |
| 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 | 2016-10-19 |