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

Catalog Number GMS805

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The following information was requested, but unavailable: the patient demographic info: age, weight, bmi at the time of index procedure the diagnosis and indication for the initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? what are the patient comorbidities/concomitant medications? product lot # were there any deficiencies or anomalies noted with versascope device during the initial surgical procedure? was the piece successfully removed from the patient's cavity? if the piece was retained, where is it located/in what structure? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? to date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent. .

Event Description

It was reported that a patient underwent a hysteroscopy on (b)(6) 2020 and the scope was used.It was reported that during an interval hysteroscopy and polypectomy on (b)(6) 2021 a 5 mm plastic remnant was found in patient's cavity.It was presumed to have become detached from device during the hysterectomy on (b)(6) 2020.

• 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: 11625976
• MDR Text Key: 247013941
• Report Number: 2210968-2021-03096
• 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,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: GMS805
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 04/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention