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

Model Number	173021
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2017
Type of Reportable Event	Malfunction
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: occurred during a laparoscopic roux-en-y gastric bypass.While oversewing the staple line, the suture slipped out of the swage of the needle.Nothing disengaged into the patient cavity.To complete the procedure, another reload was opened.No patient injury or extension in surgical time.Patient status is alive, no injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of the device.From the opened product, the needle was received without suture and appeared to have disengaged from the suture under tension.It was observed, under magnification, normal needle crimp and swage marks were observed.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; therefore, a device history record will not be performed.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.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: 6708076
• Report Number: 9612501-2017-05757
• Device Sequence Number: 108774
• Product Code: OCW
• UDI-Device Identifier: 20884521129433
• UDI-Public: 20884521129433
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2017

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: 01/31/2022
• Device Model Number: 173021
• Device Catalogue Number: 173021
• Device Lot Number: J7A0061X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Initial Date Received by Manufacturer: 06/19/2017
• Supplement Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 07/12/2017
• Supplement Report FDA Received Date: 09/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR