MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD AUTO SUTURE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	24055
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/26/2018
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, prior to use, on prepping of the case, the device plastic flanges at the base broke apart.There was no reported patient involvement and outcome.
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) led an evaluation of three devices.The visual inspection of the returned products noted that the opened device spiked trocar was received.The circular and envelope seal were intact.The flanges of the anchor were skewed and broken.The other two devices were received unopened in its original packaging.The condition of the first device precludes functional testing.Pmv performed functional testing on the second unopened device.The device was removed from its original packaging and all components functioned properly.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Replication of the reported condition may be due to insertion or removal of the port without the anchor tabs being fully closed.Under these circumstances, the tabs may be exposed to excessive force and therefore break.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AUTO SUTURE
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7245420
• Report Number: 9612501-2018-00175
• Device Sequence Number: 10996262
• Product Code: GCJ
• UDI-Device Identifier: 10884521080829
• UDI-Public: 10884521080829
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K981941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2018

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: 08/31/2018
• Device Model Number: 24055
• Device Catalogue Number: 24055
• Device Lot Number: J3H0250X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Initial Date Received by Manufacturer: 01/26/2018
• Supplement Date Received by Manufacturer: 04/07/2018
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 04/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1