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

Catalog Number 00481

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Burn(s) (1757); No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 12/01/2014

Event Type  Injury  

Event Description

It was reported that a patient underwent an electrosurgical gynecological procedure on (b)(6) 2014.During the procedure, the surgeon stopped pressing the footpedal but the electrosurgical device stayed active and there was no error message.The device was removed.No additional information was provided.

Manufacturer Narrative

(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

Manufacturer Narrative

(b)(4).It was reported that the patient underwent a gynecological procedure on (b)(6) 2014 and the electrosurgical device was used.During the procedure, the surgeon stopped pressing the footpedal, but the electrosurgical device stayed active without possibility to stop and there was no error message/code.The patient¿s consequence was burn and the surgical site was removed.

• 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): ETHICON INC.-GYRUS MEDICAL LTD; fortran road, st. mellons; cardiff CF3 O LT; UK CF3 OLT
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4370476
• MDR Text Key: 5286849
• Report Number: 2210968-2014-17123
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K040302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/10/2014

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: 00481
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2014
• Initial Date FDA Received: 12/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention