MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD DFS; STAPLE, IMPLANTABLE

Model Number	070614
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2019
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 inguinal hernia repair, when attaching the hernia mesh, the lever can be squeezed, the initial staples fired correctly, then the last one jammed.The staple was half in and half out that was stuck at the end of the stapler that was caught on the tissue.No additional treatment required.It was the final staple being fired for reinforcement.The surgeon then decided no other staples were required to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted: the stapler appeared intact.The stapler was fully fired with no staples remaining in the cartridge.There was one bent staple at the distal end of the device.It was removed and no damage to the stapler or cartridge was noted.The condition in which the device was received precludes functional testing.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DFS
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 9098451
• Report Number: 9612501-2019-01785
• Device Sequence Number: 16810381
• Product Code: GDW
• UDI-Device Identifier: 10884521080744
• UDI-Public: 10884521080744
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K780695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

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: 05/31/2023
• Device Model Number: 070614
• Device Catalogue Number: 070614
• Device Lot Number: J8E1843X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1