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 Uterine Perforation (2121); Perforation of Vessels (2135); Blood Loss (2597); No Code Available (3191)

Event Date 05/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.The patient demographic info: age, gender, weight, bmi at the time of index procedure date of initial surgical procedure.The diagnosis and indication for the initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? other relevant patient history/concomitant medications.Will the electrode be returned, return date, tracking information? what is physician¿s opinion as to the etiology of or contributing factors to this event? does the surgeon believe the generator contributed to the event? are any photos available?.

Event Description

It was reported that the patient underwent a hysteroscopy procedure on (b)(6) 2017 and an electrosurgical device was used.During the procedure, the patient moved like if she was electrocuted and the surgeon perforated the uterine.The surgeon is not sure if this happened due to electrosurgical device use.The patient was taken off the table.Coelioscopy has been proceeded and it has been found that one vessel near to iliac vessel was perforated and one laparotomy was done to stop the bleeding.Additional information has been requested.

Manufacturer Narrative

The review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.Additional information was requested and the following was obtained: date of initial surgical procedure - (b)(6)2017.The diagnosis and indication for the initial surgical procedure? - hysteroscopy and resection.What were current symptoms following the index surgical procedure? onset date ? - na / the patient suddenly moved / jumped as if she received an electric discharge, she took off from the operating table.The hysteroscope was in the hand of the surgeon and due to this event, the surgeon has perforated the patient uterus.A coelioscopy has been proceed and a venous wound near the external right iliac vein was observed.The bleeding was important so a laparotomy was performed.The electrode was used with a versapoint generator.Other relevant patient history/concomitant medications - na.Will the electrode be returned, return date, tracking information? - yes.No tracking information for the moment.What is physician¿s opinion as to the etiology of or contributing factors to this event? - not available at this time.Are any photos available? - no.Does the surgeon believe the generator contributed to the event? no more information than the ones provided in the complaint.Does the surgeon believe the generator contributed to the event? no more information than the ones provided in the complaint.Patient status: no complication.

Manufacturer Narrative

Initial investigation/inspection highlighted that there was a break in the contact former of the device connector and a small area of damage to the heat shrink.The device passed capacitance and continuity testing and with the device connected to a generator via a modified cord.Activation testing in both cut and coag modes was conducted successfully including a simulated use test.It is was considered that the damage in insulation could have caused electrical shorting between the electrode shaft and the assembled resectoscopic sheath, this in turn could have caused the shocks experienced by the patient.Dielectric strength testing could not detect a breakdown in the dielectric barrier of the device.In summary none of the testing carried out has revealed a fault or weakness with the device that could be linked to nerve stimulation.It is possible that the incident reported by the customer could be attributed to other equipment or connecting cables used during surgery, but it has not been possible to substantiate this possibility without having all components used within the surgery returned for investigation.

• 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: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6583119
• MDR Text Key: 75700748
• Report Number: 2210968-2017-32214
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• 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: UGY1610163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 70