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

Model Number	059037
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2018
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, when squeezing the trigger on the handle while closing the skin during an open procedure, the cartridge flew across the room.There was no patient injury.
Additional Manufacturer Narrative
This event has been reassessed.The event is no longer considered a malfunction reportable, and is now classified as a not reportable.If information is provided in the future, a supplemental report will be issued.

• 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: 8226890
• Report Number: 9612501-2019-00042
• Device Sequence Number: 2027022
• Product Code: GDT
• UDI-Device Identifier: 10884521080690
• UDI-Public: 10884521080690
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2019

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 Model Number: 059037
• Device Catalogue Number: 059037
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1