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 2016-07-25 for MIC1332 manufactured by Sterilmed, Inc..
[50390691]
The account's reported complaint of black residue on the device has been confirmed in previous complaints, however,microvasive biopsy forceps are manufactured with a black ink on its sheath and what the account is referring to as black residue is actually a transfer of the black ink the oem uses during production of the device. There have been no other reported complaints for this issue from other accounts. 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
[50390692]
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
[55248544]
The device was returned to the manufacturer for evaluation. The wipe down of the device with alcohol reveals that the only portions where there is a black residue where the device has been inked by the manufacturer with black stripes. This is an oem issue, directly related to the manufacture of the device. A complaint query reveals that this is the only account with the black residue complaint. As this is an oem issue, no corrective action has been issued at this time. The black residue has also been confirmed when the same wipe down was performed on an unopened oem product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2016-00054 |
| MDR Report Key | 5820176 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-07-25 |
| Date of Report | 2016-06-29 |
| Date of Event | 2016-06-28 |
| Date Mfgr Received | 2016-08-25 |
| Device Manufacturer Date | 2016-03-24 |
| Date Added to Maude | 2016-07-25 |
| 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 55449 |
| Manufacturer Country | US |
| Manufacturer Postal | 55449 |
| 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 | 2016-07-25 |
| Returned To Mfg | 2016-08-25 |
| Model Number | MIC1332 |
| Catalog Number | MIC1332 |
| Lot Number | 1936699 |
| Device Expiration Date | 2017-03-24 |
| 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 | 2016-07-25 |