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 Cardiac Tamponade (2226)

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).Device not returned.To date it has been reported that the device will not be returned.If the device or further details are received as a later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: please clarify how many patients experienced cardiac tamponade with the endoloop please clarify if the reports from (b)(4) are for the same patient.Are any of these pcs (b)(4) duplicates? no information on how many patients there are.There is no detailed information about hospital facilities or patients, but surgeons of chest surgery association have been collecting information about patients with cardiac tamponade occurred during the operation with endoloop.As the surgeons asks surgeons all over japan if there are any patients who have had cardiac tamponade occurred during the operation with endoloops, some surgeons are worried.These pcs (b)(4) are not duplicates, but surgeons of chest surgery association have the same information about this.Is it possible that there is only 1 patient involved, but the report came from 3 different sources? no information on how many patients there are.The surgeons of chest surgery association have been collecting information about patients with cardiac tamponade occurred during the operation with endoloop.Questions regarding the patient: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure date and name of index surgical 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)? no further information will be available.On what tissue was the suture used? 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.Did the cardiac tamponade occur during the procedure? no further information will be available.What was being done with the endoloop when the cardiac tamponade occurred? no further information will be available.What was done to treat the cardiac tamponade? no further information will be available.What is the alleged deficiency of the endoloop that led to the cardiac tamponade? no further information will be available.Please describe any medical/surgical intervention required for this suture event including dates and results.No further information will be available.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? no further information will be available.Other relevant patient history/concomitant medications? no further information will be available.What is the physician¿s opinion as to the etiology of or contributing factors to this event? no further information will be available.What is the patient's current status? no further information will be available.Lot number? no further information will be available.If applicable, will product be returned? no it will not be returned.If so, please provide the return date and tracking information.It will not returned.

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, cardiac tamponade occurred.No further information is available.

• 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: 16148237
• MDR Text Key: 307196891
• Report Number: 2210968-2023-00294
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• 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
• Date Manufacturer Received: 12/20/2022
• 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): Other