MAUDE Adverse Event Report: ETHICON INC. VERSAPOINT ANGLED LOOP; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 01985

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 09/05/2022

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.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.1.Was there any change in the patient¿s post-operative care due to the prolonged procedure? 2.Any medical treatment provided? if yes, please provide medicine name, strength and dose.3.What is the patient¿s current health status and condition? to date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.(b)(4).A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.

Event Description

It was reported that a patient underwent a resection of a submucous myoma of the uterus procedure on (b)(6) 2022 and an electrosurgical device was used.During the surgery, the doctor found that the electrosurgical ring was broken, and repeatedly searched for the electrosurgical ring that was not broken in the uterine cavity.The breakage of the product during the surgery affected the surgery and increased the surgery time.There were no adverse patient consequences reported.Additional information has been 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.Additional information was requested and the following was obtained: 1.Was there any change in the patient¿s post-operative care due to the prolonged procedure? no, now the patient is good.2.Any medical treatment provided? if yes, please provide medicine name, strength and dose no other treatment was performed.3.What is the patient¿s current health status and condition? it's good.

• Brand Name: VERSAPOINT ANGLED LOOP
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GYRUS MEDICAL LTD; fortran road; cardiff ; UK
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15920846
• MDR Text Key: 307914036
• Report Number: 2210968-2022-09972
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 20705031001005
• UDI-Public: 10705031001008
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K040302
• 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,Followup
• Report Date: 12/05/2022

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 Model Number: 01985
• Device Catalogue Number: 01985
• Device Lot Number: UGY1912038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 12/14/2022
• Supplement Dates FDA Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2020
• 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 Age: 43 YR
• Patient Sex: Female