MAUDE Adverse Event Report: ETHICON INC. PDS II VIO 70CM M1::USP5-0 SGLE ARM CC-1 MP; SUTURE, SURGICAL, ABSORBABLE

Catalog Number XNZ1043H

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device (b)(4) batch number, and no non-conformances were identified.Attempts are being made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent a bile ducts procedure by coelioscopy on an unknown date and suture was used.During the procedure, the strand broke when the surgeon attempted to suture the cystic canal.There were no adverse patient consequences reported.

Manufacturer Narrative

(b)(4).

• Brand Name: PDS II VIO 70CM M1::USP5-0 SGLE ARM CC-1 MP
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9523520
• MDR Text Key: 191320898
• Report Number: 2210968-2019-91362
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: XNZ1043H
• Device Lot Number: PHZ497
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2019
• Patient Sequence Number: 1