MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-23 for M/L-10 1002 manufactured by Microline Surgical, Inc..
[184482094]
Microline clip applier possibly malfunctioned. Some clips did not stay attached when other clips were placed adjacent to them.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9865027 |
| MDR Report Key | 9865027 |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-01-06 |
| Report Date | 2020-03-03 |
| Date Reported to FDA | 2020-03-03 |
| Date Reported to Mfgr | 2020-03-23 |
| Date Added to Maude | 2020-03-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | M/L-10 |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY |
| Product Code | GCJ |
| Date Received | 2020-03-23 |
| Model Number | 1002 |
| Catalog Number | 1002 |
| Lot Number | 00126772 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROLINE SURGICAL, INC. |
| Manufacturer Address | 50 DUNHAM RD BEVERLY MD 01915 US 01915 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-23 |