MAUDE Adverse Event Report: ETHICON INC. SUTURE UNKNOWN; SUTURE, ABSORBABLE

Catalog Number NW1205

Device Problem Break (1069)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/04/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 clarify the name of the index surgical procedure? was it a hysterectomy, myomectomy, other? were any concomitant procedures performed? did the patient experience any symptoms following the index surgical procedure? onset date? other relevant patient history/concomitant medications? what instruments were used to grasp the needle? where was the needle grasped during use? were x-rays performed to localize the needle fragment? what was the size of the broken needle fragment? were the needle piece(s) retrieved during the same procedure? does the piece/device remain retained in the patient's tissue? if the piece(s) were retained, where are they located/in what structure? if retained, were there any patient consequences? if retained, are there plans for removal of any remaining fragments? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? to date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.(b)(4).

Event Description

It was reported that a patient underwent a laparoscopic hysterectomyomectomy on (b)(6) 2021 and suture was used in the uterine remnant cavity.The needle broke when sewing.The surgery was converted to open laparotomy to look for the broken needle, causing the increase of bleeding.A new like device was used to complete the procedure and there were no adverse patient consequences reported.Additional information has been requested.

Manufacturer Narrative

Date sent to the fda: 10/13/2021.Additional information was requested, and the following was obtained: please provide a correct product type, code and lot number in order to investigate this complaint accurately?- local sales rep asked the hospital staff, but can't get any information on that, that means can't confirm the correctness of the lot number.The following information was requested, but unavailable- unknown: were any concomitant procedures performed? did the patient experience any symptoms following the index surgical procedure? onset date? other relevant patient history/concomitant medications? what instruments were used to grasp the needle? where was the needle grasped during use? were x-rays performed to localize the needle fragment? what was the size of the broken needle fragment? were the needle piece(s) retrieved during the same procedure? does the piece/device remain retained in the patient's tissue? if the piece(s) were retained, where are they located/in what structure? if retained, were there any patient consequences? if retained, are there plans for removal of any remaining fragments? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? 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 date sent to the fda: 10/13/2021.

Manufacturer Narrative

Date sent to the fda: 10/21/2021.Additional information was requested, and the following was obtained: the local team also can't know the name of the absorbable product.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.

• Brand Name: SUTURE UNKNOWN
• Type of Device: SUTURE, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12394469
• MDR Text Key: 269029763
• Report Number: 2210968-2021-07863
• Device Sequence Number: 1
• Product Code: GAK
• Combination Product (y/n): N
• PMA/PMN Number: K964072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: NW1205
• Device Lot Number: T8015
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2021
• Patient Sequence Number: 1
• Patient Age: 37 YR