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

Catalog Number GMS805

Device Problem Break (1069)

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

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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.Additional information was requested and the following was obtained: please clarify how many devices are involved in this single procedure what is the total number of patients? have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).Please provide lot number any patient consequences? status of product return.Gms 805/lot no: 2020092880.The scope that broke inside the patient was used by doctor and she had to retrieve it, there were no patient consequences with device.

Event Description

It was reported that a patient underwent a hysteroscopy procedure on (b)(6) 2021 and the endoscope was used.It was reported that the plastic end of the sheath detached itself into the patient's uterus and had to be retrieved.There were no adverse patient consequences reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 10/26/2021.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.: one device was returned opened in unoriginal packaging.The lot number of the device was verified.A visual inspection found the clear plastic sheath was split and peeling off at the tip of the scope.A two-year lot history review was conducted and found no other similar events reported for this lot number.Non-conformities were not observed in the dhr or lhr.Based on the product history, the upper control limit has not been exceeded in the past three months, and it does not indicate a trend, therefore no further investigation is required.

• Brand Name: VERSASCOPE INNER SHEATH
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12334301
• MDR Text Key: 267085680
• Report Number: 2210968-2021-07431
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• PMA/PMN Number: K972426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

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 Expiration Date: 02/29/2024
• Device Catalogue Number: GMS805
• Device Lot Number: 2020092880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 08/17/2021
• Supplement Dates Manufacturer Received: 09/27/2021
• Supplement Dates FDA Received: 10/26/2021
• Patient Sequence Number: 1