MAUDE Adverse Event Report: ETHICON INC. VERSAPOINT LOOP ELECTRODE ACCESSORY; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number 01985

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Date 08/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.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 a hysteroscopy with myomectomy on (b)(6) 2016 and an electrosurgical device was used.The patient due to bleeding developed water intoxication and needed a sterile flush/ sf0.9% under pressure for a long time, endotracheal intubation, icu, prolonged hospitalization and surgical re-rapprochement.It was also reported that it was not used the material of the house, the procedure was interrupted by anesthesia, due to the surgical risk, and although it was mounted and not used.Additional information will be requested.

Manufacturer Narrative

Additional information was requested and the following was received: other relevant patient history/concomitant medications - no.What is physicians opinion as to the etiology of or contributing factors to this event? - the problem occurred due to failure of equipment and disposable (sic).Where did the bleeding occur? - uterine cavity, site of surgery.What is the patients current status? - discharged and monitoring.

Manufacturer Narrative

Visually the device appeared to have had very minimal use.When electrically tested the electrode displayed values within device specification.When functionally tested the device displayed the correct default settings and activated in saline in both cut and coag modes without any generator errors.The fault could not be replicated.

• Brand Name: VERSAPOINT LOOP ELECTRODE ACCESSORY
• 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: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 6000937
• MDR Text Key: 56500686
• Report Number: 2210968-2016-14212
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01985
• Device Lot Number: UGY1507156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention