MAUDE Adverse Event Report: RICHARD WOLF GMBH PIRANHA; MOTOR CONTROL UNIT

Model Number 2303011

Device Problems Device Displays Incorrect Message (2591); Connection Problem (2900); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2021

Event Type  malfunction  

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 Description

It was reported to rw by the user facility that: the pump was in use and after they changed to the 4th canister the machine would go back to treatment mode and then say check for leaks or pressure wasn't right.They changed the tubing, filter, canister, motor and blade but nothing seemed to correct it.They are hoping to bring the patients back tomorrow to get the rest of the tissue out if we can get them the loaners.Additional information: will the device be returned? yes.Was the device being used on a patient when the reporting issue occurred? yes.There any injury or illness to the patient due to the reported issue? no.Was there any injury or illness to any other personnel due to the reported issue? no.Did the issue cause a delay in the procedure being performed? yes.Did the delay put the patient at risk? no.Was there a similar back-up device available for use? no.Was the scheduled procedure completed? no.

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh.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.Follow-up report #1 is to provide fda with missing information, new information, and changed information.See also mdr 1418479-2021-00034.

Event Description

The purpose of this report is to add patient and other information received from the user facility as part of due diligence.According the user facility, the doctor was performing a laser enucleation of prostate with morcellation.The device was set to three when suction control failed.

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, and changed information.Device labeling was reviewed for patient code and device codes, see below: patient code: not applicable, no patient problem was reported.Device code: not applicable, no device problem found.Rwmic considers this mdr closed.Should rw receive new information, a follow-up report will be submitted.

Event Description

The purpose of this submission is to report the results of the device evaluation.The device was evaluated using visual and functional means.The reported condition, machine would go back to treatment mode and say check for leaks or pressure, was not confirmed.No device problem (2303.011 - motor control unit) found.Findings as reported by the manufacturer: according to the manufacturer, the "motor control unit 2303.011 was tested, also in combination of the device from cmpt (b)(4) (1418479-2021-00034) suction pump.No defect of the motor control unit 2303.011 was detected.The motor control unit 2303.011 works properly.The reported issues was caused by the device from complaint (b)(4) (1418479-2021-00034).The device was returned to the customer.

• Brand Name: PIRANHA
• Type of Device: MOTOR CONTROL UNIT
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 12241657
• MDR Text Key: 264488436
• Report Number: 1418479-2021-00035
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 04055207056653
• UDI-Public: 04055207056653
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2303011
• Device Catalogue Number: 2303.011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SUCTION PUMP. 2208011
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White