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

Model Number 173016

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/28/2018

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 total laparoscopic hysterectomy, while suturing the vaginal cuff at the colpotomy, the needle fell out of the suturing device in three of the reloads.It was reported that the first suturing device and suture worked well.When the second suture was loaded, the needle fell out.A new suture was opened, but it fell out as well.A second suturing device and a fourth suture were opened, but the needle fell out again.The fifth suture was opened and the case was completed.The needles were retrieved in all cases.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection and functional testing confirmed there were no abnormalities that would have caused or contributed to the reported condition.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.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a total laparoscopic hysterectomy, while suturing the vaginal cuff at the colpotomy, the needle fell out of the suturing device in three of the reloads.It was reported that the first suturing device and suture worked well.When the second suture was loaded, the needle fell out.A new suture was opened but it fell out as well.A second suturing device and a fourth suture was opened, but the needle fell out again.The fifth suture was opened and case was completed.The needles were retrieved in all cases.There was no patient injury.

• 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
• MDR Report Key: 8269306
• MDR Text Key: 133838168
• Report Number: 9612501-2019-00138
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10884521100008
• UDI-Public: 10884521100008
• Combination Product (y/n): N
• PMA/PMN Number: K934738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: J8D1528EX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Initial Date Manufacturer Received: 12/28/2018
• Initial Date FDA Received: 01/22/2019
• Supplement Dates Manufacturer Received: 02/06/2019
• Supplement Dates FDA Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1