MAUDE Adverse Event Report: RICHARD WOLF GMBH PIRANHA SUCTION PUMP

Model Number 2208011

Device Problems Pumping Problem (3016); Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Rwmic considers this case open.The user facility and manufacturer will be contacted again in an effort to collect missing information.

Event Description

On (b)(6) 2018, the user facility reported the following to richard wolf medical instruments (rwmic): "the piranha is presenting difficulties during interventions.The equipment is shutting down several times during the procedures and the morcellator also has speed changes".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? unknown.Was there any injury or illness to patient or other personnel due to issue? unknown.Did the issue cause a delay in the procedure being performed that put the patient at risk? unknown.Was there a similar back-up device available for use? unknown.Was the scheduled procedure completed? unknown.How was the patient anesthetized? unknown.On march 13, 2019, rwmic received additional information from the sales representative: was the device being used on a patient when the issue occurred? yes.Was there any injury or illness to the patient or other personnel due to this issue? no.Did the issue cause a delay in the procedure being performed that put the patient at risk? yes.Was there a back-up device available for use? no.Was the scheduled procedure completed? yes, with great difficulty.Was the patient anesthetized? yes.

Manufacturer Narrative

Device labeling was reviewed for patient and device codes, see below: patient code: not applicable, no patient problem was reported.Device code: ifu was reviewed, see below: important! run through the checks before and after each use.Do not use products which are damaged, incomplete or have loose parts.Return damaged products together with any loose parts for repair.Do not attempt to do any repairs yourself.Caution! the products have only limited strength! exerting excessive force may lead to damage, impair the function and therefore endanger the patient.Check the products for damage, loose parts and completeness immediately before and after each use.Make sure no missing instrument parts remain in the patient.Do not use products that are damaged, incomplete or have loose parts.Attempts were made to collect additional/missing information from the user facility, but no additional information could be provided.Rwmic considers this case closed.Should additional information become available a follow up report will be submitted.

Event Description

The user facility returned the device to richard wolf medical instruments corporation (rwmic) on march 12, 2019 and the device evaluation was completed on july 16, 2019.The device was visually, functionally, and electrically evaluated.The reported condition was verified as the connection to the double silencer was found to be broken off, resulting in no pressure build-up.The cause can be traced to leakage during vacuum build-up during application.The leak was due to the user not following the ifu.The device did not meet specifications, but there was no manufacturing defect identified.The device was repaired.

• Brand Name: PIRANHA SUCTION PUMP
• Type of Device: PIRANHA SUCTION PUMP
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 8511436
• MDR Text Key: 148428183
• Report Number: 1418479-2019-00013
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 04055207011874
• UDI-Public: 04055207011874
• 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
• Type of Report: Initial,Followup
• Report Date: 08/09/2019,03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2208011
• Device Catalogue Number: 2208011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/09/2019
• Distributor Facility Aware Date: 03/13/2019
• Device Age: 3 YR
• Date Report to Manufacturer: 08/09/2019
• Date Manufacturer Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other