MAUDE Adverse Event Report: ETHICON INC. VERSASCOPE INNER SHEATH; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number GMS805

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 09/02/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and mesh was used.The packaging was unsealed resulting in loss of sterility.A device from another lot was used and there were no adverse patient consequences.No further information was provided.

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 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.(b)(4).

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.H3 analysis summary: received one gms805 in original packaging.Lot number was verified.Performed a visual inspection, the hole for the scope to enter through is misaligned.Performed a functional inspection, the scope cannot be inserted into the device.A two-year review of similar events revealed an occurrence rate of 0.001 for this device.Based on the product history, the upper control limit has been exceeded in the past 3 months; however, the single point does not exceed 3 devices.A two-year lot history review was conducted and found no other similar events reported for this lot number.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.

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.Updated h3 analysis summary: according to the information received, unsealed packaging.Loss of sterility.Use of device from another lot.Reported event of the device not having a proper seal is confirmed.Received three gms805 in original packaging.Lot number was verified.Performed a visual inspection, the packaging was not sealed at one end.Performed a functional inspection, the scope cannot be inserted into the device.(b)(4).Based on the product history, the upper control limit has been exceeded in the past 3 months; however, the single point does not exceed 3 devices.A two-year lot history review was conducted and found no other similar events reported for this lot number.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Related events captured via 2210968-2022-09045, 2210968-2023-01350 and 2210968-2023-01351.

• Brand Name: VERSASCOPE INNER SHEATH
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): CONMED; 11311 concept blvd.; largo FL 33773
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15715926
• MDR Text Key: 307172692
• Report Number: 2210968-2022-09045
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K972426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: GMS805
• Device Lot Number: 2020091480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2020
• 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