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

Model Number EZ10G

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2022

Event Type  malfunction  

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 was unavailable: in event description indicates "the suture could not be pulled after the canula was snapped", could you please provide more details? no further information will be available.Could you please confirm, did the suture broke? no further information will be available.Did the suture stay in the patients body? please confirm if it was possible to take out the suture during the surgery: no further information will be available.If applicable, it was needed another surgery to get the suture out from patient's body? no further information will be available.Device return follow up.The device has been received at sukagawa and will be shipped.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.

Event Description

It was reported that a patient underwent a unknown procedure on (b)(6) 2022 and suture was used.During the procedure, the suture could not be pulled after the canula was snapped.Another device was used to complete the case.There were no patient consequences reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 8/23/2022.H6 component code: g07002 no device problem found.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and functional tests were conducted on the returned device.Visual analysis of the returned sample determined that one opened sample of product code ez10 was received for evaluation.The device was removed from the original packet and the loop is open, no damaged or breakage suture could be observed in the sample.The scored point was noted broken due to use and the knot was configured correctly and conform to the visual standard.A functional test was performed to sample and the knot is closed until the end without problems.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.Standard endoscopic procedures should be followed up to the point of tissue ligation or approximation.The endoloop ligature is then introduced through a cannula.An appropriate surgical instrument is used to grasp and position the tissue.This may involve either pulling the tissue through the loop or encompassing the tissue with the loop.The endoloop ligature tube is then broken at the scored point.This allows the tube to slide over the suture and cinches the loop around the tissue.When the ligature has provided hemostasis, the suture is cut behind the knot leaving an appropriate length of suture ¿ear¿.The tube is then removed.Several ligatures may be applied to ensure hemostasis or tissue approximation.The event described could not be confirmed as the device performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.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: 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 ; BR
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15180106
• MDR Text Key: 304992986
• Report Number: 2210968-2022-06357
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EZ10G
• Device Catalogue Number: EZ10G
• Device Lot Number: AR6307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2022
• 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