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)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a roux-en-y laparoscopic procedure, while closing a defect in the bowel, the suture separated from the swedge of the needle.A new device was used to complete the procedure.As the needle is now stuck in the device this is only because the surgeon broke the device over his knee so it will not be in working condition.There was no injury caused to the patient and no medical intervention was required as a result of the device issue.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Needle was improperly loaded in device.Needle could not be unloaded from device.Proper swage marks were observed for the needle.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.However, the investigation detected an improperly loaded needle that may have a relationship to the reported incident.The root cause of the observed condition was misuse of the product which would have caused or contributed to the reported incident.Replication of an improperly loaded needle may occur if either the dlu has incorrect orientation or the suturing device is held with the printed information facing down when the needle is loaded in the device.In some instances the needle becomes lodged in between the jaw and the slot of the blade of the suturing device making it impossible to unload.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: 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: 6931655
• Report Number: 9612501-2017-06367
• Device Sequence Number: 1239419
• 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): 01/17/2018

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: 07/31/2021
• Device Model Number: 173021
• Device Catalogue Number: 173021
• Device Lot Number: J6G1448RX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2017
• Initial Date Received by Manufacturer: 09/12/2017
• Supplement Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 10/09/2017
• Supplement Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1