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

Model Number 173016

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic roux en-y, on the second suture, when the surgeon was toggling the suture, the handle suddenly broke and it appeared a screw fell out.There was no patient injury.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Device screw which functions as a fulcrum for handle was not present in the device.Signs that a screw had been installed were observed.Device functioned properly when it was tested after another screw was installed.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.The root cause of the reported condition could not be reliably determined as the screw was not returned with the device.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic roux en-y, on the second suture, when the surgeon was toggling the suture, the handle suddenly broke and it appeared a screw fell out.A new device was opened to complete the case.There was no patient injury.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO STITCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7443834
• MDR Text Key: 106015472
• Report Number: 9612501-2018-00795
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10884521100008
• UDI-Public: 10884521100008
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: J8A0026EX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 47 YR