MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-05-24 for MIC1333 manufactured by Sterilmed, Inc..
[15802535]
Final investigation showed that the device was stiff during opening and closing of the jaws. The jaw was found to be properly aligned, and there was no damage to the edges of the jaw which would lead to dullness.
Patient Sequence No: 1, Text Type: N, H10
[15860973]
It was reported that use of a biopsy forceps damaged tissue around the biopsy site, causing bruising and swelling that was not normal. Additional follow up with the endo manager and charge nurse for this case confirmed the complaint, with the additional comment that lack of a sharp bite caused bleeding and added unnecessary time to the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2012-00170 |
| MDR Report Key | 2590748 |
| Report Source | 05,07 |
| Date Received | 2012-05-24 |
| Date of Report | 2011-05-19 |
| Date Added to Maude | 2012-06-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | TRICIA SCHRATER |
| Manufacturer Street | 11400 73RD AVE. NORTH |
| Manufacturer City | MAPLE GROVE MN 55369 |
| Manufacturer Country | US |
| Manufacturer Postal | 55369 |
| Manufacturer Phone | 7634883211 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | BIOPSY FORCEPS (NON) |
| Product Code | NON |
| Date Received | 2012-05-24 |
| Returned To Mfg | 2011-05-25 |
| Model Number | MIC1333 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-24 |