MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-15 for SCALPFIX STERILE FF013P manufactured by Aesculap Ag.
[133221066]
(b)(4). Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[133221067]
It was reported that there was an intraoperative issue with the sterile scalpfix devices. During a craniotomy on (b)(6) 2018, the scalpfix reloads were noted as jamming. After every second clip was dispensed, the magazine jammed. The surgeon requested the non-disposable gun for application and the issue again occurred; a second disposable product was also opened. There was a delay in surgery of 20 minutes due to the malfunction. There was no other intervention required. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00020 |
| MDR Report Key | 8250738 |
| Date Received | 2019-01-15 |
| Date of Report | 2019-01-28 |
| Date of Event | 2018-11-01 |
| Date Facility Aware | 2019-01-24 |
| Date Mfgr Received | 2019-01-24 |
| Date Added to Maude | 2019-01-15 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SCALPFIX STERILE |
| Generic Name | MICRO NEUROSURGICAL INSTR. / D |
| Product Code | HBO |
| Date Received | 2019-01-15 |
| Model Number | FF013P |
| Catalog Number | FF013P |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-15 |