MAUDE Adverse Event Report: ETHICON INC. 0 ENDOLOOP LIG W/PDS II; CANNULA, SURGICAL, GENERAL AND PLASTIC SURGERY

Model Number EZ10G

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/01/2022

Event Type  Injury  

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.(b)(4).Attempts are being 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 initial procedure? the diagnosis and indication for the index surgical 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)? how was the suture originally tied (multiple knots, square knot, etc.)? when did the bleeding occur (date/number of days post-op)? what was the source and triggering event of bleeding? what was the volume of blood loss? how was the bleeding treated? what type of drainage was placed? please describe any medical/surgical intervention required for this suture event including dates and results.Were there any deficiencies or anomalies noted with the device prior to, during or after the procedure? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? lot number? if applicable, will product be returned? if so, please provide the return date and tracking information.

Event Description

It was reported that a patient underwent a partial pneumonectomy on (b)(6) 2022 and suture was used to cut lung parenchyma.After the patient was discharged from the hospital, bleeding occurred.The patient was re-hospitalized, and drainage was placed, but no additional operation was performed.The surgeon commented that the cause of the bleeding is unknown, but there is a possibility that the end loop caught on something and caused the bleeding.Additional information was requested.

Manufacturer Narrative

(b)(4).Date sent to the fda: 9/9/2022.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.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 date of initial procedure? => no further information will be available.The diagnosis and indication for the index surgical procedure? => no further information will be available.What was the initial approach for the index surgical procedure? (open, laparoscopic or other)? => the lung partial resection.On what tissue was the suture used? => the device was used at the initial operation to cut lung parenchyma.No further information will be available.What was the tissue condition (normal, thin, calcified, fragile, diseased)? => no further information will be available.How was the suture placed (interrupted or continuous)? => no further information will be available.How was the suture originally tied (multiple knots, square knot, etc.)? => no further information will be available.When did the bleeding occur (date/number of days post-op)? => bleeding occurred after the patient discharged from the hospital.No further information will be available.What was the source and triggering event of bleeding? => no further information will be available.What was the volume of blood loss? => the amount of bleeding is a little.How was the bleeding treated? => drainage was placed.No reoperation.What type of drainage was placed? => no further information will be available.Please describe any medical/surgical intervention required for this suture event including dates and results.Were there any deficiencies or anomalies noted with the device prior to, during or after the procedure? => drainage was placed.No reoperation.What is the physician¿s opinion as to the etiology of or contributing factors to this event? => the surgeon commented that the cause of the bleeding is unknown, but there is a possibility that the end loop caught on something and caused the bleeding.No further information will be available.What is the patient's current status? => the patient is stable.Lot number? =>lot# is unknown.No further information will be available.If applicable, will product be returned? => no device will be returned.No further information will be available.If so, please provide the return date and tracking information.=> we regularly contact with sale rep about the device returning.No further information will be available.No further information will be provided.

• Brand Name: 0 ENDOLOOP LIG W/PDS II
• Type of Device: CANNULA, SURGICAL, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra; km 154; sao paolo 12240 -908; BR 12240-908
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15216631
• MDR Text Key: 297775070
• Report Number: 2210968-2022-06514
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 10705031206427
• UDI-Public: 10705031206427
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K843187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EZ10G
• Device Catalogue Number: EZ10G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2022
• 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): Required Intervention