MAUDE Adverse Event Report: ETHICON INC. COATED VICRYL; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	VCP260H
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The tip of the suture needle broke during tvh procedure as follows; once the posterior uterus was freed from the rectum the peritoneum was then picked up and entered sharply with metzenbaum scissors.A deaver ski slope weighted speculum was placed within the peritoneum.At this time we visualized the uterosacral ligaments.These were clamped with a heaney clamp and ligated with #0 vicryl suture.A heaney clamp and vicryl was then used to match up the bilateral uterine pedicles in an alternating fashion until the uterus was freed up and removed.The tubes and ovaries were not visualized on either side.We then removed the weighted duckbill speculum and used a sponge stick to push away the bowel and visualize the entire area.We inspected for hemostasis.There was some bleeding of the right distal pedicle that was secured with a hemostatic stitch.At this time the needle tip was noted to be broken.

• Brand Name: COATED VICRYL
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; rt. 22 west; p.o. box 151; somerville NJ 08876
• MDR Report Key: 8603221
• Report Number: 8603221
• Device Sequence Number: 2510869
• Product Code: GAM
• UDI-Device Identifier: 10705031051805
• UDI-Public: (01)10705031051805
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/07/2019
• Report Date (Section F): 05/07/2019

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
• Operator of Device: Health Professional
• Device Model Number: VCP260H
• Device Catalogue Number: VCP260H
• Device Lot Number: MM7896
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2019
• Patient Sequence Number: 1
• Patient Weight: 82
• Date Report Sent to FDA: 05/07/2019