MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD MULTIFIRE PREMIUM; STAPLE, REMOVABLE (SKIN)

Model Number	059037
Medical Device Problem Codes	Failure to Fire (2610); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during an open reduction and internal fixation c6-7 fracture with optical tracking, the two skin staplers did not fire when triggered, then the magazine fell out/became detached from the staple gun.The devices were removed to resolve the issue.There was no patient injury.

• Brand Name: MULTIFIRE PREMIUM
• Common Device Name: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 8628239
• Report Number: 9612501-2019-00996
• Device Sequence Number: 14017618
• Product Code: GDT
• UDI-Device Identifier: 10884521080690
• UDI-Public: 10884521080690
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 059037
• Device Catalogue Number: 059037
• Device Lot Number: J9A0478Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 113