MAUDE Adverse Event Report: ETHICON INC. 4.0MM VERSAPOINT RESECTING LOO; COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR

Catalog Number 01942

Device Problem Break (1069)

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

Event Date 11/18/2020

Event Type  malfunction  

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.Were there any patient consequences? was any broken piece left in the patients body? was there any change in the patient¿s post-operative care due to the prolonged procedure? a manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.Product release date: april 2020.Product expiry date: april 2025.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.

Event Description

It was reported that a patient underwent an unknown gynecological procedure on (b)(6) 2020 and an electrode was used.The handle broke during the procedure.The team had to wait 55 minutes until another electrode arrived.The procedure was completed using a new like device and there were no adverse patient consequences reported.Additional information was requested.

Manufacturer Narrative

Product complaint (b)(4).Date sent to the fda: 4/1/2021.Additional information: d9, h3.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.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, 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.Product complaint (b)(4).Date sent to the fda: 4/1/2021.Corrected information: d3, g1.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, 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.

Manufacturer Narrative

(b)(4).Date sent to fda: 05/12/2021.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, 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.H3 analysis summary: the device has not been returned in its original packaging.The active ring of the device is confirmed to be missing from the distal end of the electrode.The missing section of the active ring has been returned with the electrode.The remainder of the electrode show no signs of damage.No connector cable has been returned with the electrode.No electrical or functional testing will be conducted due to the condition of the device.Closer visual examination will only be conducted.All fracture faces show evidence of a brittle failure, also there are no signs of an obvious reduction on cross sectional area, indicating a non-mechanical failure mode.It is also worth noting that the fracture surfaces may have been compromised somewhat as activation may have occurred after the actual failure causing the fracture surface to be altered somewhat.Potentially, indicating failure due to surface (hydrogen) embrittlement.The device history record for batch referenced above was reviewed for non-conformances related to the nature of the complaint during the manufacturing process.The results of this review indicate there were zero non-conformances regarding the nature of the complaint associated with this lot.Product release date: april 2020.Product expiry date: april 2025.(b)(4).Date sent to fda: 05/12/2021.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, 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: 4.0MM VERSAPOINT RESECTING LOO
• Type of Device: COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 10976315
• MDR Text Key: 220454098
• Report Number: 2210968-2020-09764
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• PMA/PMN Number: K111751
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 01942
• Device Lot Number: UGY2004012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 03/03/2021; 04/19/2021
• Supplement Dates FDA Received: 04/01/2021; 05/12/2021
• Patient Sequence Number: 1
• Patient Age: 40 YR