MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SOFSILK; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	170004
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Codes	Radiation Exposure, Unintended (3164); No Code Available (3191)
Date of Event	09/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during a laparoscopic hernia repair, the needle broke in the cavity and couldn't be retrieved right away.The doctor had to perform x-rays to find the needle and it was eventually retrieved.Surgery time was extended over 30 minutes and there was very little blood loss.The patient is currently fine.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of two device.Needle one pieces were broken at the suture swage.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 bent or broken needle may occur when the needle is not loaded properly or when the needle is forced into an obstacle.This condition may also occur if excess pressure is exerted on the needle or the attached suture while the jaws are in the open position.In these situations, the needle may flex and ultimately 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: SOFSILK
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 6908524
• Report Number: 9612501-2017-06312
• Device Sequence Number: 108902
• Product Code: OCW
• UDI-Device Identifier: 20884521126906
• UDI-Public: 20884521126906
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K934738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 170004
• Device Catalogue Number: 170004
• Device Lot Number: J7D0480X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 10/31/2017
• Initial Report FDA Received Date: 10/02/2017
• Supplement Report FDA Received Date: 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other