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 2016-06-09 for MIC1332 manufactured by Sterilmed, Inc..
[46917917]
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
[46917918]
It was reported that following a procedure, during cleaning with tap water and a gauze, black residue was noticed on the device. There has been no patient harm or consequence reported. Follow up has been requested should any further patient information come available.
Patient Sequence No: 1, Text Type: D, B5
[49641452]
The device was returned in good visual condition. During evaluation, the entire length of the device shaft was wiped down with tap water and produced light black residue marks on the cloth as reported by the user facility. A second wipe down with 70% isopropyl alcohol was then performed. It was discovered that while performing the second wipe down over the black lines on the shaft, the transfer of black residue on the cloth was heavier. There was no transfer of black residue observed on the cloth when wiping down the orange section of the shaft. In order to determine root cause, fifteen unused, reprocessed devices of the same model were then evaluated. Findings from this evaluation showed the same black residue coming off the black lines and transferring onto the cloth. The devices are manufactured with a black ink on the sheath. The black residue was identified as a transfer of black ink that is used in original device production by the original equipment manufacturer (oem). An evaluation was also performed on a new non-reprocessed oem device and the same findings were observed indicating that the cause of the issue is not associated with reprocessing. There have been no other reported complaints for this issue from other facilities. The device history record was reviewed and no discrepancies were noted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2016-00040 |
| MDR Report Key | 5709753 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-06-09 |
| Date of Report | 2016-05-17 |
| Date of Event | 2016-05-13 |
| Date Mfgr Received | 2016-07-15 |
| Device Manufacturer Date | 2016-02-28 |
| Date Added to Maude | 2016-06-09 |
| 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 | 2016-06-09 |
| Returned To Mfg | 2016-06-07 |
| Model Number | MIC1332 |
| Catalog Number | MIC1332 |
| Lot Number | 1931478 |
| Device Expiration Date | 2017-02-28 |
| 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 | 2016-06-09 |