MAUDE Adverse Event Report: RICHARD WOLF GMBH HOOK ELECTRODE MONOPOLAR

Model Number	8383.423
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rwmic has requested additional and missing information from the user facility and manufacturer.Rwmic will submit a follow up report upon receipt of additional information as appropriate.Rwmic consider this case open.
Event or Problem Description
On (b)(6) 2019, the user facility reported the following to richard wolf medical instruments corporation (rwmic): the cable sparked during the procedure.No patient injury.Will the device be returned? yes.Was the device being used during a procedure when the issue occurred? yes.Specifically, was the device being used on a patient when the issue occurred? no.Was there any injury or illness to patient or other personnel due to issue? no.Did the issue cause a delay in the procedure being performed that put the patient at risk? no.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.How was the patient anesthetized? general.

• Brand Name: HOOK ELECTRODE MONOPOLAR
• Common Device Name: HOOK ELECTRODE MONOPOLAR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 8757859
• Report Number: 1418479-2019-00028
• Device Sequence Number: 19343005
• Product Code: GEI
• UDI-Device Identifier: 04055207015001
• UDI-Public: 04055207015001
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K964329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/04/2019
• Report Date (Section F): 07/03/2019

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
• Operator of Device: No Information
• Device Model Number: 8383.423
• Device Catalogue Number: 8383.423
• Device Lot Number: 61006041
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 07/03/2019
• 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: Required Intervention
• Date Report Sent to FDA: 07/03/2019