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 2016-08-29 for MIC1332 manufactured by Sterilmed, Inc..
[53439543]
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
[53439544]
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 forceps broke. Fragments or pieces were not left in the patient. No harm was detected to patient. Additional information was requested, but additional information is not available.
Patient Sequence No: 1, Text Type: D, B5
[55811306]
The device was returned to the manufacturer and subjected to evaluation. The device had a severe kink in the length of the device denoting a visual failure. The device was subjected to function testing. The jaws of the device did not respond to the actuation of the handle with 100 % consistency. The jaws would open and partially close, or sometimes hardly change in position. The root cause for the defect is uncertain, though the device may have been damaged during its use in the field.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2016-00064 |
| MDR Report Key | 5912504 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-08-29 |
| Date of Report | 2016-09-27 |
| Date Mfgr Received | 2016-09-26 |
| Device Manufacturer Date | 2016-04-11 |
| Date Added to Maude | 2016-08-29 |
| 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 PARKWAY SUITE 2 |
| Manufacturer City | PLYMOUTH MN 55426 |
| Manufacturer Country | US |
| Manufacturer Postal | 55426 |
| 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 | 2016-08-29 |
| Returned To Mfg | 2016-09-26 |
| Model Number | MIC1332 |
| Catalog Number | MIC1332 |
| Lot Number | 1940202 |
| Device Expiration Date | 2017-04-11 |
| 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 | 2016-08-29 |