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

Catalog Number GMS805

Device Problem Break (1069)

Patient Problem Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).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.The patient demographic info: age, weight, bmi at the time of index procedure.Date and name of initial surgical procedure.The diagnosis and indication for the initial surgical procedure? what are the patient comorbidities/concomitant medications? patient symptoms manifestations (location, severity, appearance, systemic or local reaction).Date - time of onset of infection and vaginal discharge from the surgical procedure? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were cultures performed? results? product lot #.Please provide date and details of the re-operation.What is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status?.

Event Description

It was reported that a patient underwent a hysteroscopy procedure on an unknown date and the endoscope was used.It was reported that the plastic end of the sheath contributed to a suspected uterine perforation.It was reported that the device only tore when it was introduced to biopsy forceps during the procedure.It was also reported that the device was okay with just the sheath, but not with taking any biopsy.Additional information was requested.

Manufacturer Narrative

Product complaint#: (b)(4).Date sent to the fda: 03/04/2022.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.H3: evaluation: one device was received in unoriginal packaging.Lot number was not verified.A visual inspection was performed, and the clear sheath had a melted appearance and was split open.A two-year review of similar events revealed an occurrence (b)(4) for this device.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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• 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: 12635690
• MDR Text Key: 281004301
• Report Number: 2210968-2021-09701
• 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,Followup,Followup
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: GMS805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female