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

Model Number	24055-
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104); Packaging Problem (3007)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Radiation Exposure, Unintended (3164); Device Embedded In Tissue or Plaque (3165)
Date of Event	07/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopic hernia repair, the device seal disengaged, cannula and obturator broke, the product parts disintegrated and surgeon was unable to retrieve all pieces.A new product was opened but it collapsed, a forth (4th) was opened and worked to complete the case.The patient is alive with injury.
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of two devices.The visual inspection of the returned products noted; the spiked trocars were received.The circular and envelope seals were intact.The flanges of the anchors were skewed and broken.Returned with the devices were four photographs which appear to show the devices on tissue.The condition of the devices 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.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: 6795297
• Report Number: 9612501-2017-05967
• Device Sequence Number: 103096
• Product Code: GCJ
• UDI-Device Identifier: 10884521080829
• UDI-Public: 10884521080829
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K981941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2017

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: 10/31/2018
• Device Model Number: 24055-
• Device Catalogue Number: 24055-
• Device Lot Number: J3K1947X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 08/15/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1