MAUDE Adverse Event Report: RICHARD WOLF GMBH PIRANHA; FOOTSWITCH 1 PEDAL

Model Number	2030108
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of richard wolf (b)(4).Richard wolf medical instruments corporation is the importer of this device.Rwmic considers this mdr/complaint open.Rwmic will submit a follow up report after the device evaluation has been completed and/or new information becomes available.
Event or Problem Description
It was reported by the user facility: not suctioning.We've reached out to the user facility for additional information.
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Follow-up report #1 is to provide fda with new and changed information.New information: the following fields have new information: section a, b3 - b5, d8, d10, g2, g3, g6, h2, h6, h8, h10.Changed information: the following fields have changed information: e1, rwmic considers this mdr/complaint open.Rwmic will submit a follow up report after the device evaluation has been completed and/or new information becomes available.
Event or Problem Description
The purpose of this submission is to report the additional information received from the user facility.Describe event: holep pump not providing suction, makes it difficult to morcellate the prostate.The device malfunction increased length of case.
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Follow-up report #2 is to provide fda with missing information, new information (results of the device evaluation), and changed information.New information: the following fields have new information: b5, g2, h2, h7, h10.Changed information: the following fields have changed information: h3.Device investigation: according to the results of the device investigation, the foot switch (2030.108) was tested (using visual and functional methods), also in combination of devices from cmpt 21-00330 a and b (mdrs 1418479-2021-00042, -00043.No device problem was found.The customer's complaint could not be reproduced on the device.The device was returned to the customer.Rwmic considers this mdr closed.Rwmic will submit a follow up report when new information becomes available.
Event or Problem Description
The purpose of this submission is to report the results of the device investigation.Please see manufacturers narrative.

• Brand Name: PIRANHA
• Common Device Name: FOOTSWITCH 1 PEDAL
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• MDR Report Key: 12518826
• Report Number: 1418479-2021-00044
• Device Sequence Number: 5159767
• Product Code: JCX
• UDI-Device Identifier: 04055207054734
• UDI-Public: 04055207054734
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K042523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2021

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: Health Professional
• Device Model Number: 2030108
• Device Catalogue Number: 2030108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 09/13/2021; 11/16/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 09/27/2021; 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONNECTING TUBE8170.6554; LASER MASTERPULSE HOLIUM FORTEC; PIRANHA SUCTION PUMP2208011
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Race: White