MAUDE Adverse Event Report: RICHARD WOLF GMBH ENDOSCOPIC ELECTROSURGICAL DIATHERMY SYSTEM ELECTRODE, REUSABLE

Model Number 8426.142

Device Problems Device Disinfection Or Sterilization Issue (2909); Material Deformation (2976)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2016

Event Type  malfunction  

Manufacturer Narrative

Actual device recently received at manufacturing facility.Investigation/evaluation currently in process.(b)(4) considers this report open, follow-up report to be submitted once investigation is complete.

Event Description

During a turp procedure, facility opened device packaging and noticed the insulation around the loop on the device had come away.Device in question was not used on patient.Back up device was readily available and procedure completed as scheduled.No injury to patient or staff reported.

Manufacturer Narrative

After review of processes after device left the manufacturing facility (b)(4), it was revealed that the device in question was irradiated with gamma.This led to a change in the material characteristic by hardening the isolation tube and making it brittle.The distributor was informed by email that richard wolf (b)(4), as manufacturer of the non-sterile, reusable electrodes (type no.8426.142; cutting electrode) does not allow gamma irradiation.This is clearly addressed in detail in the instruction for use (ifu) for this device.Any deficiency can be easily detected by the user in visual and functional inspection before use and in this case damaged electrode was found prior to use and not used in treatment of any patients.Richard wolf (b)(4) is not aware of any similar cases.Further measures have not been scheduled.Investigation results also submitted to (b)(4)'s regulatory authority.(b)(4) considers this report to be closed.If any additional information is received concerning this event, an additional follow up report will be provided.(b)(4).

Manufacturer Narrative

Correction made to d.4.Model # should be 8426.142.

• Brand Name: ENDOSCOPIC ELECTROSURGICAL DIATHERMY SYSTEM ELECTRODE, REUSABLE
• Type of Device: ELECTRODE
• Manufacturer (Section D): RICHARD WOLF GMBH; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: oliver ehrlich ; 32 pforzheimer street; knittlingen, 75438 ; GM 75438 ; 043351013
• MDR Report Key: 5464006
• MDR Text Key: 39201872
• Report Number: 9611102-2016-00001
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8426.142
• Device Lot Number: 1273068
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2016
• Initial Date FDA Received: 02/26/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/31/2016; 09/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1