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

Catalog Number GMS805

Device Problem Fracture (1260)

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

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested and the following was obtained: please provide lot number of the two devices.Any patient consequences?, status of product return, no patient consequences.Lot: 2020092180, evaluation: investigation was based on device evaluation and photographic evidence.One product was returned opened in unoriginal packaging.The lot number of the device was not verified.A visual inspection confirmed the clear plastic sheath was split and peeling off at the tip of the scope.A two-year review of similar events revealed an occurrence rate of 0.0001 for this device.Based on the product history, the upper control limit has not been exceeded in the past three months, the complaint was not confirmed, and it does not indicate a trend, therefore no further investigation is required.A two-year lot history review was conducted and found 2 similar events involving 2 devices reported for this lot number.Review of the dhr found the product was produced per current and approved procedures and material specifications.Non-conformities were not observed in the dhr or lhr.Associated events reported via mw# 2210968-2021-07431.

Event Description

It was reported that a patient underwent a hysteroscopy procedure on (b)(4) 2021 and the endoscope was used.It was reported that the plastic end of the sheath split.Upon evaluation of the returned sample it was found that there was white sheath tip damage.There were no adverse patient consequences reported.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: 13820795
• MDR Text Key: 287701550
• Report Number: 2210968-2022-01907
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/18/2022

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 Expiration Date: 02/29/2024
• Device Catalogue Number: GMS805
• Device Lot Number: 2020092180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Initial Date Manufacturer Received: 02/16/2022
• Initial Date FDA Received: 03/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1