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

Model Number	170043
Medical Device Problem Codes	Detachment Of Device Component (1104); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2018
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 procedure, the device was difficult to toggle, load and unload.The device was hard to operate.Two different needles fell out of the jaw when it was properly loaded and in the locked position.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of a label of one device.Only the product label was returned, this showed no abnormalities.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.Without the physical product, a definitive root cause could not be identified.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGIDAC
• 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: 7620379
• Report Number: 9612501-2018-01134
• Device Sequence Number: 1590284
• Product Code: OCW
• UDI-Device Identifier: 10884521128972
• UDI-Public: 10884521128972
• 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): 09/21/2018

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: 05/31/2022
• Device Model Number: 170043
• Device Catalogue Number: 170043
• Device Lot Number: J7E1197X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Initial Date Received by Manufacturer: 06/05/2018
• Supplement Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1