MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-11 for SAFEVIEW ENDOSCOPIC SOFT TISSUE RELEASE SYSTEM manufactured by Mission Surgical Innovations.
[94659835]
During course of endoscopic carpal tunnel release, blade broke off in pt's wrist. All parts retrieved. Procedure completed without further complications or harm to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073901 |
| MDR Report Key | 7108284 |
| Date Received | 2017-12-11 |
| Date of Report | 2017-11-30 |
| Date of Event | 2017-11-27 |
| Date Added to Maude | 2017-12-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SAFEVIEW ENDOSCOPIC SOFT TISSUE RELEASE SYSTEM |
| Generic Name | BLADE, ORTHOPEDIC SURGICAL INSTRUMENT |
| Product Code | EMF |
| Date Received | 2017-12-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MISSION SURGICAL INNOVATIONS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-11 |