MAUDE Adverse Event Report: COVIDIEN ENDO STITCH; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Catalog Number VLOCA208L

Device Problems Break (1069); Detachment Of Device Component (1104); Entrapment of Device (1212); Sticking (1597)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/04/2016

Event Type  malfunction  

Event Description

Nursing: during total laparoscopic hysterectomy, the surgeon was using the endo stitch suturing device with the v-loc 180 absorbable reload and the suture needle broke.All pieces were found, one piece was stuck in the endo stitch device itself.Surgeon: there was slight bleeding at the right edge, and the v-loc suture was placed in the corner of the vagina, incorporating vaginal mucosa and controlling the bleeding.A 2nd bite was taken and, unfortunately, the needle broke loose from the device.The suture was then cut.The needle was removed from the vaginal cuff and handed off.The remainder of the needle was found lodged within the device.All of the needle was accounted for.The suture that had been left long at that right angle was then cut.A 2nd v-loc suture was obtained and used to close the vaginal cuff in a running fashion.

• Brand Name: ENDO STITCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 5646265
• MDR Text Key: 44896734
• Report Number: 5646265
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/01/2017
• Device Catalogue Number: VLOCA208L
• Device Lot Number: N4M0743X
• Other Device ID Number: 1303351
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 120