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

Model Number	173026
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2018
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 gastric bypass procedure, the needle broke while stitching the patient's stomach.The needle was recovered prior to the end of the procedure.There was no patient harm.

• 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: 7938815
• Report Number: 9612501-2018-01769
• Device Sequence Number: 11241329
• Product Code: OCW
• UDI-Device Identifier: 10884521129467
• UDI-Public: 10884521129467
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K934738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2018

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: 02/28/2023
• Device Model Number: 173026
• Device Catalogue Number: 173026
• Device Lot Number: J8B0017X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR