MAUDE Adverse Event Report: RICHARD WOLF GMBH PIRANHA SUCTION PUMP

Model Number 2208011

Device Problems Difficult to Open or Close (2921); Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/03/2018

Event Type  malfunction  

Manufacturer Narrative

Richard wolf medical instrument corporation considers this complaint and mdr open.User facility will be contacted to provide missing information.The manufacturer will also be contacted again to collect device information.Rwmic will provide follow-up reports as required.Device labeling was reviewed for patient code and device codes, see below: patient code: not applicable, no patient problem was reported.Device code: ifu was reviewed, section 4 checks: 'important! run through the checks before and after each use.Do not use the products if they are damaged or incomplete or have loose parts.Return damaged products together with any loose parts for repair.Do no attempt to do any repairs yourself.Section 4.1 visual check: "check the device and accessories for damaged, loose or missing parts, hygiene and completeness.

Event Description

Description of the problem as reported by sales associate for rwmic.Information was provided in an email dated (b)(6) 2018: "i received a service call from the customer about the issues of piranha morcellator not sucking in prostate lobes into vmax blade from (b)(6) a dr.(b)(6) surgical site.(original complaint) i then covered the next two holep cases.(i have sold over 8 piranha systems and covered over 100 cases) i observed and heard the suction valve clamp is not opening fully in suction and piranha mode on foot pedal.The prostate lobe is not engaging the vmax blade.I had to keep my hand over the black suction valve clamp throughout the completion of the morcellation.We then took the action of sending (b)(6) a loaner piranha suction unit while we observed their unit.The unit was evaluated by rwmic and we determined there was not an issue.During the evaluation period the account did not have an issue with service loaner (b)(6) unit was returned unrepaired and the issue happened again today during the first case of re installation.The circulator nurse in the room had to hold her hand on the suction valve clamp during morcellation.Lets get them a loaner asap.He does over a 100 holeps a year." user facility was asked the following questions, answers were provided on 7/5/2018: 1.Was the device being used during a procedure when the issue occurred? yes.2.Specifically, was the device being used on a patient when the issue occurred? yes.3.Was there any injury or illness to patient or other personnel due to issue? no.4.Did the issue cause a delay in the procedure being performed that put the patient at risk? yes.5.Was there a similar back-up device available for use? no.6.Was the scheduled procedure completed? yes.7.How was the patient anesthetized? general, local, unknown, not applicable? unknown.User facility return the device to rwmic for repair on 7/12/2018.Investigation report was completed on 07/18/2018, summary below: product appearance is used.Condition was verified.Suction valve opens but valve bracket is broken.Testing was completed with 2030108 and suction tube set.And a pressure meter.Root cause is shipping damage, the suction valve was loose, internal mounting bracket was damaged and was replaced.Device was repaired, function tested, and returned to customer.

Manufacturer Narrative

Richard wolf medical instruments corporation attempted to obtain additional information from the user facility but no response was provided.Rwmic considers this case closed.

• Brand Name: PIRANHA SUCTION PUMP
• Type of Device: SUCTION PUMP
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 7741118
• MDR Text Key: 116053613
• Report Number: 1418479-2018-00009
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: K041610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 08/01/2018,09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• 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: 07/12/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2018
• Distributor Facility Aware Date: 07/03/2018
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/01/2018
• Date Manufacturer Received: 07/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other