MAUDE Adverse Event Report: RICHARD WOLF GMBH CUTTING ELECTRODE BIPO 24CH 12/30

Model Number	8622131
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reclaimed cutting electrode (b)(4) is not a sterile product.The cutting electrode is delivered in a blister packaging.The blister packaging is not an indicator for the evidence that a product has gone through the sterilization process.As indicators for a sterile product the marking "sterile" as well as the expiry date or the date of manufacturing are imprinted on the packaging of a sterile product.The user should have recognized this on the basis of the not imprinted indicators for a sterile product or on the basis of the reference to the ifu (b)(4) on the label.The ifu (b)(4) of the device informs the user as follows: 8.1.4 electrodes important! for sterile products: sterility is only guaranteed for undamaged and unopened packaging.=>do not use the product if the sterile packaging is damaged or the use-by date is exceeded.- disposable electrodes, sterile =>check sterile packaging.9.2 electrodes important! only electrodes with a product number starting with "8" can be reprocessed.Disposable electrodes with model/type numbers starting with "4" may only be used once.Discard disposable electrodes after use.Potential hazards were considered in the risk assessment b2-3 regarding the appropriate extent of damage and the likelihood of occurrence.It was considered as an acceptable risk.This assessment is still valid in consideration of the current case.It can be reasonably assumed that the use of the electrode without processing does not occur in accordance with the correct procedure considering the available information.On the basis of the available examination results from our point of view no corrective actions are necessary.(b)(4) considers this report closed.Richard wolf medical instrument corporation( rwmic) submitting report on behalf of richard wolf (b)(4) ((b)(4) )(manufacturer) rwmic is obtaining additional information from the manufacturer (b)(4) and will submit follow up report upon receipt of additional information.
Event or Problem Description
Richard wolf (b)(4), hereinafter referred to as (b)(4) was notified of an event that occurred at the user facility on an unspecified date.It was reported that the surgical team at the hospital used (b)(4) cutting electrode (b)(4) (blister packaging) in operations without prior treatment.The hospital considered the cutting electrode to be sterile.The cutting electrode was discarded by the customer.There was no report of adverse outcome to the patient as a consequence of this event.No other information is available.

• Brand Name: CUTTING ELECTRODE BIPO 24CH 12/30
• Common Device Name: CUTTING ELECTRODE BIPO 24CH 12/30
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, gm 75438 ; GM 75438
• MDR Report Key: 7885655
• Report Number: 9611102-2018-00014
• Device Sequence Number: 1819178
• Product Code: FAS
• UDI-Device Identifier: 04055207018019
• UDI-Public: 04055207018019
• Combination Product (Y/N): N
• PMA/510(K) Number: K062720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Remedial Action: Other,Inspection
• Type of Report: Initial
• Report Date (Section B): 08/29/2018

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?: No
• Operator of Device: No Information
• Device Model Number: 8622131
• Device Catalogue Number: 8622131
• Device Lot Number: 1378439
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other