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

Model Number 2208011

Device Problems Protective Measures Problem (3015); Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The present suction pump with the serial number (b)(4) originates from batch 1323598 and was created on 09/23/3016 in a lot size of 6 pieces.No anomalies were noted during the manufacturing process.The inspection revealed a thermally deformed double silencer (74011060).The double silencer is supplied by metzger technik.Due to the continuous operation of the pump and overheating at the outlet, the double silencer does not switch off and is thermally overheated and deformed.The cause can be traced back to a leak during vacuum build-up during application.Possible causes can be the hose set, bacteria filter or float valve.There is no direct patient risk from the evaluation of the available information.The user is warned by the loud operating noises and the error message "vacuum build-up error" that there is a leak in the structure during the visual function check before the application.The ga-a252 contains sufficient instructions for visual and functional checks as well as for proper use.In the risk assessment e3-1, possible risks to the product with the corresponding extent of damage and the assumed probability of occurrence were considered and assessed with an acceptable risk.In order to prevent possible equipment failure, a second, equivalent pump should be available.No systematic deficiencies can be derived from the inspection of the pump from a manufacturing or design point of view.Based on this result no construction/user errors are possible.This case is considered closed.Should any additional information become available, a follow up will be provided.

Event Description

On october 01, 2019, richard wolf medical instruments corporation (rwmic) received the following information: during morcellation the unit stopped working.There was a triangle error code and the alarm went off.There was no patient injury and the case was not completed.

• Brand Name: PIRANHA
• Type of Device: 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: heiko seider-biedermann ; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10077708
• MDR Text Key: 208365349
• Report Number: 1418479-2019-00024
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 04055207011874
• UDI-Public: 04055207011874
• 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: user facility
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/20/2020,10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• 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?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/20/2020
• Distributor Facility Aware Date: 10/01/2019
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2020
• Date Manufacturer Received: 05/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2016
• 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
• Patient Outcome(s): Other