MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-28 for SCALP CLIP CARTRIDGE UNKNOWN FF013P manufactured by Aesculap, Inc..
[36986366]
Patient Sequence No: 1, Text Type: N, H10
[36986367]
The scalp gun would not fire the scalp clips to attach to the patient's scalp. A new gun was opened and it still wouldn't work. The clip cartridge was replaced and it still wouldn't work properly. Two scalp clips fired but did not attach to the patient as appropriate. All four items were removed from the field with the exception of the 2 failed scalp clips which were visible in the craniotomy drape. Raney clip appliers were opened and raney clips were opened and used instead. Upon inspection, it appears that one gun was working properly but the cartridges would not fire on either gun. All items will be turned in for further inspection at the end of the case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5396021 |
| MDR Report Key | 5396021 |
| Date Received | 2016-01-28 |
| Date of Report | 2015-11-18 |
| Date of Event | 2015-01-23 |
| Report Date | 2015-11-18 |
| Date Reported to FDA | 2015-11-18 |
| Date Reported to Mfgr | 2015-11-18 |
| Date Added to Maude | 2016-01-28 |
| 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 | 0 |
| 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 | 3 |
| Brand Name | SCALP CLIP CARTRIDGE |
| Generic Name | CLIP, SCALP |
| Product Code | HBO |
| Date Received | 2016-01-28 |
| Returned To Mfg | 2015-04-28 |
| Model Number | UNKNOWN |
| Catalog Number | FF013P |
| Lot Number | UNKNOWN |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP, INC. |
| Manufacturer Address | 3773 CORPORATE PARKWAY CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-28 |