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

Model Number 2208011

Device Problems Fluid/Blood Leak (1250); Suction Problem (2170); Misassembled During Installation (4049)

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

Event Date 03/08/2022

Event Type  malfunction  

Manufacturer Narrative

Rwmic considers this mdr 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 richard wolf that "unit malfunctioned during a procedure.Message on suction pump read "suction pump defective-service required/needed".No back-up was available.Surgeon preformed a laser procedure." additional information reported by the user facility: will the device be returned? yes.Was the device being used on a patient when the reporting issue occurred? yes.Was there any injury or illness to the patient due to the reported issue? unknown.Was there any injury or illness to any other personnel due to the reported issue? unknown.Did the issue cause a delay in the procedure being performed? yes.Did the delay put the patient at risk? yes.Was there a similar back-up device available for use? no.Was the scheduled procedure completed? no.According to the sales rep: could you reach out to the user facility to confirm the following? 1.Did the delay in the procedure put the patient at risk? - no.2.Briefly describe the risk to the patient, or why there was no risk to the patient.- the account performed another procedure on the patient.3.Did the surgical method had to be changed? - yes.4.Was the rest of the system checked? - yes.5.Will or can other components be sent back for evaluation? - the component was sent for evaluation.In addition to your request for answers to the 'unknown' patient impact questions, could you also ask for a more detailed description on 1.What is defective on the device? (from the original complaint description) suction pump.2.What happened during the procedure and how was it "ugly"? the account did not say it was ugly.Because the suction pump didn't work, the case was delayed; which i'm sure did not make the surgeon very happy.3.What malfunctioned on the device? suction pump.4.Are the other components of the piranha system functioning correctly? no.We provided a suction pump loaner to them and they will be testing the components to make sure they work.If they don't, they will be returned.5.Are the other components of the system available for return? no.Because there was a report of a delay, i'll need additional information to confirm there was risk to the patient.Please reach out to the sales rep or the customer to ask the following questions; 1.How long was the procedure delayed? 15 minutes.2.What actions were being done during the delay? preparing instrumentation to perform a laser procedure.3.Did the patient require any additional treatment during the delay or will require another procedure as the result of the delay? no.4.What was the risk to the patient? none.5.What was the patient's outcome? ok.

Event Description

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

Manufacturer Narrative

Follow-up report #1 is to provide fda with new and missing information.Missing information: user facility was contacted three times in an effort to collect patient information and user information.As of 5/20/2022, rwmic has not received a response.The results of the device investigation: according to the manufacturer, the "suction pump 2208011 with serial number 1100405574 was tested according to the work instruction aaw03-098-0630.There was moisture in the system causing the reported issue.Also the pump got stuck due to the moisture in the system.The root cause of the moisture in the system is due to leakage and missing secretion filter.The user is advised in the related ifu ga-a252-usa/en/2012-07/pdg 11-5360 to use the secretion filter and to check the entire system before each use.The suction pump 2208011 with the serial number (b)(6) was produced on 12/19/2017 and it was delivered to rwmic on 01/10/2018.According to sap, the suction pump was delivered to the user facility on 07/16/2018.No further maintenance or repair records were found regarding this device, a material failure or a manufacturing defect can be ruled out.Test method: visual and functional means; the probable root cause: user error; reported condition confirmed: yes; devices meets specifications: no; product disposition: repair.While rwmic considers this mdr closed, we will submit a follow-up report should any new information be received.

• Brand Name: PIRANHA
• Type of Device: SUCTION PUMP
• 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: colleen tobin ; 353 corporate woods pkwy; vernon hills, IL 60061 ; 8479550775
• MDR Report Key: 13928286
• MDR Text Key: 298148102
• Report Number: 9611102-2022-00013
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 04055207011874
• UDI-Public: 04055207011874
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K041610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/09/2022

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
• Device Operator: Health Professional
• Device Model Number: 2208011
• Device Catalogue Number: 2208011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2022
• Initial Date FDA Received: 03/28/2022
• Supplement Dates Manufacturer Received: 03/10/2022
• Supplement Dates FDA Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1