MAUDE Adverse Event Report: RICHARD WOLF GMBH PIRANHA SUCTION PUMP

Model Number 2208001

Device Problems Suction Problem (2170); Suction Failure (4039)

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Date 04/09/2019

Event Type  Injury  

Manufacturer Narrative

Rwmic will follow up with the user facility and manufacturer to obtain additional and missing information.Rwmic considers this case open.

Event Description

On (b)(4) 2019, a richard wolf medical instruments corporation (rwmic) sales representative reported the following: the system was having suction issues and the facility wanted to return the devices for repair.A loaner was provided to the user facility, but the malfunctioning devices were not immediately returned to rwmic for repair.The sales representative contacted the complaints specialist on (b)(4) 2019, and reported that the malfunctioning devices were used again during another case that same day, (b)(6) 2019.The system had suction issues, which resulted in part of the patient's bladder being sucked into the pump.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? yes.Was there any injury or illness to patient or other personnel due to issue? yes.Did the issue cause a delay in the procedure being performed that put the patient at risk? yes.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.How was the patient anesthetized? unknown.The following components were returned to rwmic and sent to the legal manufacturer for evaluation: motor control unit - part #2303011, serial # (b)(4) (mdr 1418479-2019-00016), suction pump - part # 2208001, serial # (b)(4) (mdr 1418479-2019-00017), the motor hand piece, part # 8564.021, serial # (b)(4) (mdr 1418479-2019-00018), has not yet been returned.

Event Description

The purpose of this submission is to report the results of the device investigation with the fda.

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.This mdr is being submitted as part of an ongoing retrospective review (remediation) of prior files by rwmic.Follow-up report #1 is to provide fda with missing and new information.Missing information: user facility was contacted 3 times (through the sales rep) in an effort to collect patient information and user information without success.Results of the device investigation: test method: visual, functional, electrical and mechanical means findings: complaint investigation is based on the assessment of the available information from the repair performed 10/28/2019.Upon investigation at the time the item was received from customer, there were no notes or issues indicated on the roc and no problem was found by the technician.Unit meet specifications and was returned to the customer.Probable root cause: no device/problem found, reported condition confirmed: no, device meets specifications: yes, product disposition: maintenance.Rwmic considers this mdr closed.Should rw receive new information, a follow-up report will be submitted.

• Brand Name: PIRANHA SUCTION PUMP
• Type of Device: PIRANHA SUCTION PUMP
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: oliver ehrlich ; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 8562802
• MDR Text Key: 143542124
• Report Number: 1418479-2019-00017
• Device Sequence Number: 1
• Product Code: JCX
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2019,06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 2208001
• Device Catalogue Number: 2208001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/29/2019
• Distributor Facility Aware Date: 04/09/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2019
• Date Manufacturer Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention