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

Model Number	059035
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product is not sold in us and is 510(k) exempt.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during an open craniotomy procedure, while attaching the drapes to the patient¿s scalp, the handle of the 1st device broke.It was noted that when closing the scalp at the end pf the procedure, the cartridge of the 2nd device inadvertently disengaged from handle.Multiple staplers were used in place of two staplers to complete the case.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: 8737140
• Report Number: 9612501-2019-01254
• Device Sequence Number: 2271133
• Product Code: GDT
• UDI-Device Identifier: 10884521080676
• UDI-Public: 10884521080676
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2019

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: 09/30/2023
• Device Model Number: 059035
• Device Catalogue Number: 059035
• Device Lot Number: J8J0021X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1