MAUDE Adverse Event Report: RICHARD WOLF GMBH MOTOR HAND PIECE

Model Number 8564.021

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 (b)(6) 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

The following fields contain new/changed information: b5, f7, f8, f9, f11, f13, g4, g7, h2, h3, h4 h6, h10 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 the products if they are damaged or incomplete or have loose parts.Return damaged products together with any loose parts for repair.Do not attempt to do any repairs yourself.Important! morcellation must only be carried out with power stick m4! during morcellation power stick m3 can become clogged by tissue parts in the handle.Important! work only with the recommended speed settings and under continuous irrigation.If the speed is set too high or if there is no irrigation the inner blade can seize or wear out quickly.If the speed is too low it can clog up.If the suction channel is clogged by tissue parts, morcellation is adversely affected.Clean a clogged suction channel with a suitable cleaning brush.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 april 12, 2019 and the device evaluation was completed on july 09, 2019.The device was visually, functionally, and electrically evaluated.The reported condition could not be verified, the inspection of the handpiece did not reveal any function-relevant defects in accordance with the inspection instructions.The device met specfications and there was no manfuacturing defect identified.

• Brand Name: MOTOR HAND PIECE
• Type of Device: MOTOR HAND PIECE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 8511545
• MDR Text Key: 147763021
• Report Number: 1418479-2019-00015
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• PMA/PMN Number: K030082
• 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: 8564.021
• Device Catalogue Number: 8564.021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/09/2019
• Distributor Facility Aware Date: 03/13/2019
• Device Age: 5 YR
• Date Report to Manufacturer: 08/09/2019
• Date Manufacturer Received: 07/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other