MAUDE Adverse Event Report: ETHICON INC. MERS TAPE WHT 12INX3/16IN S/A MO-4; CLASS I DEVICE - EXEMPT

Catalog Number	RS23
Medical Device Problem Codes	Material Separation (1562); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H6 component code: g07002 device not returned.Attempts have been 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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure date of index surgical procedure? what was the tissue condition (normal, thin, calcified, fragile, diseased)? please describe any medical/surgical intervention required for this suture event including dates and results.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? what was the volume of blood loss? how was the bleeding treated? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? if applicable, will product be returned? if so, please provide the return date and tracking information.Surgeon¿s name? a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent a cervical cerclage placement on an unknown date and suture tape was used.The surgeon passed the suture a couple of times and then the needle popped off the suture as surgeon was pulling the suture.Surgeon had to remove and start over which caused bleeding due to being highly vascular.Blood loss of 80.Surgeon used new box with different lot and was able to finish the case.Patient would have went home same day but will now have to stay overnight for monitoring due to blood loss.Additional information was requested.
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.The returned sample revealed that it was received one detached needle and one suture that pertained to product code rs23.During visual inspection of the detached needle, the swage area was noted with marks by a surgical instrument.The hole was examined under magnification and suture remnant was observed.In addition, the suture was inspected, and the end was noted to be cut probably caused by a surgical instrument.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Additional information was requested, and the following was obtained: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Unknown.Date of index surgical procedure? (b)(6) 2024 what was the tissue condition (normal, thin, calcified, fragile, diseased)? unknown please describe any medical/surgical intervention required for this suture event including dates and results.Only intervention that surgeon stated was that he had to remove the suture that was placed first so that he could use another suture to start over.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? unknown.What was the volume of blood loss? 80.How was the bleeding treated? unknown.Other relevant patient history/concomitant medications? unknown.What is the physician¿s opinion as to the etiology of or contributing factors to this event? unknown.What is the patient's current status? spoke to surgeon the following day and he said patient was doing okay.If applicable, will product be returned? if so, please provide the return date and tracking information.Already returned.Surgeon¿s name? dr.(b)(6).

• Brand Name: MERS TAPE WHT 12INX3/16IN S/A MO-4
• Common Device Name: CLASS I DEVICE - EXEMPT
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18662083
• Report Number: 2210968-2024-01103
• Device Sequence Number: 17971321
• Product Code: KDC
• UDI-Device Identifier: 10705031049826
• UDI-Public: 10705031049826
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: RS23
• Device Lot Number: TEBJCM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2024
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown