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

Lot Number SDMMOJ

Device Problem Material Separation (1562)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/02/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a cervical conization.On (b)(6) 2023 and suture was used.The patient was admitted to the hospital for "one month after cervical abnormality was found", and cervical biopsy showed that the cervical high-grade squamous intraepithelial lesions.The patient underwent the cervical conization surgery.When the surgical incision was sutured, the problem of pulling off suture needle happened.Changed to another one to complete the surgery.The event caused prolonged surgery time, excessive bleeding, and increased surgical costs for the patient.Additional information was requested.

Manufacturer Narrative

(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.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.The lot number provided sdmmoj is invalid.Please provide the correct product code and lot.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.What was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? what instruments were used to grasp the needle? where was the needle grasped during use? what was the source and triggering event of bleeding? did the pull off suture needle cause or contribute to the excessive bleeding? if yes, please explain.What was the volume of blood loss? how was the bleeding treated? please describe any medical/surgical intervention required including results.Were x-rays performed to localize the needle fragment? was the needle 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, are there plans for removal of any remaining fragments? how many minutes was the procedure prolonged due to the pull off suture needle? was additional dissection required in other tissues other than the target tissue in order to find the needle? if yes, please describe.Was the patient treatment or post-operative care altered in anyway due to the prolonged surgery time? if yes, please explain.Was there any patient impact (ie.Additional treatment required) and/or adverse patient outcome due to the prolonged surgery? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? 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? surgeon¿s name? if applicable, will product be returned? if so, please provide the return date and tracking information.

Manufacturer Narrative

(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.The following information was requested, but unavailable: the lot number provided sdmmoj is invalid.Please provide the correct product code and lot.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? what instruments were used to grasp the needle? where was the needle grasped during use? what was the source and triggering event of bleeding? did the pull off suture needle cause or contribute to the excessive bleeding? if yes, please explain.What was the volume of blood loss? how was the bleeding treated? please describe any medical/surgical intervention required including results.Were x-rays performed to localize the needle fragment? was the needle 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, are there plans for removal of any remaining fragments? how many minutes was the procedure prolonged due to the pull off suture needle? was additional dissection required in other tissues other than the target tissue in order to find the needle? if yes, please describe.Was the patient treatment or post-operative care altered in anyway due to the prolonged surgery time? if yes, please explain.Was there any patient impact (ie.Additional treatment required) and/or adverse patient outcome due to the prolonged surgery? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? 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? surgeon¿s name? if applicable, will product be returned? if so, please provide the return date and tracking information.--contacted with the sales rep today via phone, please refer to the event description and other information requested is unknown.

• Brand Name: SUTURE UNKNOWN
• Type of Device: SUTURE, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17267499
• MDR Text Key: 318545260
• Report Number: 2210968-2023-04857
• Device Sequence Number: 1
• Product Code: GAK
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: SDMMOJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Sex: Female