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

Model Number	170002
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Tissue Damage (2104); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/08/2018
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, during a laparoscopic gastric bypass, the needle was difficult to toggle and would not slide through the tissue.So they physically had to slide the tissue off of the needle which caused a larger than normal hole in the tissue from the needle.4 devices were causing issues during the case.They kept trying to get a new device and the new ones were still causing issues.There was sticking when toggling the device, loading and unloading, the device would also click loudly on some when being toggled and the needle was loose on some as well.More devices were opened to complete the case.The tissue was stretched due to struggling to get the needle out of the tissue so the hole was larger than normal.There was no patient injury.
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of one device.Visual inspection and functional testing confirmed there were no abnormalities that would have caused or contributed to the reported condition.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: 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: 7641343
• Report Number: 9612501-2018-01200
• Device Sequence Number: 2512722
• Product Code: OCW
• UDI-Device Identifier: 20884521126852
• UDI-Public: 20884521126852
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K934738
• 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,Followup
• Report Date (Section B): 10/01/2018

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 Model Number: 170002
• Device Catalogue Number: 170002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Initial Date Received by Manufacturer: 06/08/2018
• Supplement Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 10/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1