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

Catalog Number GMS805

Device Problem Material Integrity Problem (2978)

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

Event Date 12/01/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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, 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 were 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.Please provide lot number.Evaluation: received one device in unoriginal packaging.Lot numbers were not verified.Performed a visual inspection, the clear sheath is damaged at the distal end of the device.The scope was able to be inserted within the sheath.Based on the product history, there are no confirmed units above the upper limit in the past three months, and it does not indicate a trend, therefore no further investigation is required.A two-year lot history review cannot be conducted as no lot number was provided.

Event Description

It was reported that a patient underwent an unknown gynecological procedure on an unknown date in (b)(6) of 2021 and the before procedure nurse noticed that the hysteroscope was used.It was reported that the sheath is not good.It was also reported that the device is not possible to insert into the sheath.Upon evaluation of the returned sample it was found that the clear sheath was damaged at the distal end of the device.The scope was able to be inserted within the sheath.Additional information was requested.

• 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; 525 french road; utica NY 13502 5994
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14074879
• MDR Text Key: 298599480
• Report Number: 2210968-2022-02571
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K972426
• 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
• Report Date: 04/11/2022

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 Catalogue Number: GMS805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female