MAUDE Adverse Event Report: ETHICON INC. MERS TAPE WHT 30CMX5MM D/A CTX; INSTRUMENT, SURGICAL, DISPOSABLE

Catalog Number RS22

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 a patient underwent a laparoscopic cervical cerclage on (b)(6) 2019 and suture was used.During the procedure, the needle pull off.It was retrieved from patient.Changed to another one to complete.There were no adverse patient consequences reported.No additional information was provided.

Manufacturer Narrative

(b)(4).Date sent to the fda: 07/10/2019.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: MERS TAPE WHT 30CMX5MM D/A CTX
• Type of Device: INSTRUMENT, SURGICAL, DISPOSABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8727478
• MDR Text Key: 148968468
• Report Number: 2210968-2019-83184
• Device Sequence Number: 1
• Product Code: KDC
• UDI-Device Identifier: 10705031049802
• UDI-Public: 10705031049802
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: RS22
• Device Lot Number: MDH999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2019
• Patient Sequence Number: 1