MAUDE Adverse Event Report: ETHICON INC. MERS TAPE WHT 12INX3/16IN D/A CTX; CLASS I DEVICE - EXEMPT

Model Number RS22

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint: (b)(4).Component code: (b)(4) device not returned.A manufacturing record evaluation was performed for the finished device lot number pkp116 / enrs2246, and no non-conformance's related to the reported complaint condition were identified.Summary: the product was not returned to ethicon inc for evaluation.Visual inspection was conducted on the pictures received.Visual analysis of the two pictures received determined that a sealed sample of product code es22 could be observed.The reported condition could not be observed in the picture.No conclusion could be reached as to what caused the reported complaint since the sample was not returned for analysis.Additional information was requested, and the following was obtained: what was used to complete the procedure? a new suture of the same code was used to complete the procedure did the needle fell inside the patient when it separated from the suture? if yes, how was it retrieved? for example, switched to an open procedure, second surgery?- the needle was inside the patient when it was pulled away from the suture material.The needle was removed through the trocar.Could you please confirm the device's (or a sample from the same lot) availability for return ? if available, please provide the device return status/follow up.Sample is available.(another thread from this batch).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that the patient underwent a laparoscopic "circling"/cerclage procedure on (b)(6) 2021 and the suture was used.During the surgery, at the stage of suturing on the external cervical os, the needle separated from the suture material.The needle was inside the patient when it was pulled away from the suture material.The needle was removed through the trocar.There were no patient consequences reported.Another like suture was used to complete the procedure.

• Brand Name: MERS TAPE WHT 12INX3/16IN D/A CTX
• Type of Device: CLASS I DEVICE - EXEMPT
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982road183km8.3; san lorenzo PR
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11668784
• MDR Text Key: 245562506
• Report Number: 2210968-2021-03382
• Device Sequence Number: 1
• Product Code: KDC
• UDI-Device Identifier: 10705031049802
• UDI-Public: 10705031049802
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RS22
• Device Catalogue Number: RS22
• Device Lot Number: PKP116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1