MAUDE Adverse Event Report: AESCULAP, INC. SCALP CLIP CARTRIDGE; CLIP, SCALP

Model Number UNKNOWN

Device Problem Failure to Fire (2610)

Patient Problem Failure to Anastomose (1028)

Event Date 01/23/2015

Event Type  malfunction  

Event Description

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.

• Brand Name: SCALP CLIP CARTRIDGE
• Type of Device: CLIP, SCALP
• Manufacturer (Section D): AESCULAP, INC.; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 5396021
• MDR Text Key: 36986367
• Report Number: 5396021
• Device Sequence Number: 1
• Product Code: HBO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Device Catalogue Number: FF013P
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR