MAUDE Adverse Event Report: ETHICON INC. VERSAPOINT RESECTOSCOPIC SYSTEM; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number 00482

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Perforation (2001); No Code Available (3191)

Event Date 08/19/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported that the patient underwent an electrosurgical procedure of resection of the urethral valves due to urethral valves obstruct on (b)(6) 2015.After having located the valves, the doctors proceeded to their cutting, operating the system's cutting footswitch.All pressure over the footswitch was removed, and once the cystoscope had been repositioned in order to proceed with the cutting of the valves, the cutting system functioned spontaneously and without any use of it.This lasted for about 10 seconds, after which the cystoscope was immediately removed.The patient suffered a tear in the urethral valves and bladder which obliged the patient to be one month with a foley catheter and 3 post-surgeries.No additional information is available.

Manufacturer Narrative

Date sent to fda: 07/29/2016.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

Additional information: performed functional testing on the device, and ran the device through burn in testing.Could not duplicate the customer's complaint and no problems were found with the device.

• Brand Name: VERSAPOINT RESECTOSCOPIC SYSTEM
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): DEFAULT ORGANIZATION; 4545 creek rd ml # 36; cincinnati OH 45242 2803
• Manufacturer Contact: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 5783319
• MDR Text Key: 49195700
• Report Number: 2210968-2016-10298
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K040302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00482
• Device Lot Number: 0622082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 DA