MAUDE Adverse Event Report: RICHARD WOLF GMBH PIRANHA; SUCTION PUMP

Model Number	2208011
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility has informed richard wolf medical instruments corporation (rwmic) of an issue regarding a suction pump, part id: 2208011, serial # (b)(6).According to the initial reporter, the morcellator malfunctioned during a procedure and no longer provided suction.There was no reported delay in the procedure and no additional treatment required.A similar back-up device was available and the scheduled procedure was completed.There is no report of injury to the patient as well as, any other personnel.However, rwmic opted to submit a report in accordance with the fda guidance document medical device reporting for manufacturers, which requires an mdr as previous complaints involving device, 2208011, with similar issue were reported as a serious injury.This matter was considered as a reportable malfunction.
Additional Manufacturer Narrative
New information: h6 (type of investigation, investigation findings, investigation conclusions).The suction pump, part id: 2208011, serial#: (b)(6), was initially reported as malfunction due to inadequate suction during a case.Problem is traced to be caused by another device.The issue was resolved in the field.The suction pump type 2208011, serial no.(b)(6) was manufactured on 05/aug/2019.The motor handpiece max.6000rpm type 8564.021 with serial number (b)(6) was manufactured on 24/sep/2020.Both, the inspection of the manufacturing process plan showed no abnormalities.The customer "(b)(6) center" received the suction pump, type 2208011 on 31/mar/2020.The pump has therefore been in use by the customer for more than four years.Also, the motor handpiece max.6000rpm type 8564.021 was received on 12/jan/2021.The handpiece has therefore been in use by the customer for more than three years.During this time, the devices has not been at rwgmbh for repair.Based on the period of use, a product or manufacturing defect can be ruled out.According to the received information from the user facility, the suction pump, 2208011 was tested and the results showed no functional impairments.The doctor who tested the reported device concluded that the machine has operated normally.In addition, the user facility conducted a comprehensive inspection of all handpiece.During the suction testing, they identified one of the handpiece, was missing the blue o-ring in the locking collar.This finding was confirmed during suction testing, which indicated that this particular handpiece has caused the decreased of suction in the suction pump, 2208011.Furthermore, they reviewed case reports and confirmed that the motor hand piece max.6000rpm, part id: 8564.021, serial#: (b)(6) which lacking the o-ring, was indeed used during the incident in question.Based on the provided information's, there was clearly a customer fault and the inadequate suction during the case is not directly related to the suction pump.

• Brand Name: PIRANHA
• Common Device Name: SUCTION PUMP
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: valentin felsing ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 19755218
• Report Number: 9611102-2024-00024
• Device Sequence Number: 15099667
• Product Code: JCX
• UDI-Device Identifier: 04055207011874
• UDI-Public: 04055207011874
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K041610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2024

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: Other
• Device Model Number: 2208011
• Device Catalogue Number: 2208011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2019
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MOTOR HANDPIECE MAX. 6000RPM, PART ID: 8564.021; SERIAL#: (B)(6).
• Patient Sex: Unknown