MAUDE Adverse Event Report: RICHARD WOLF GMBH NEEDLE PUSHER WL 210MM

Model Number	826750
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of the device is in progress.The device is currently being returned by the user to rw (b)(4), and a follow-up report will be submitted as soon as the investigation is completed.
Event or Problem Description
Richard wolf (b)(4) received the following information on may 07, 2020: the operation " microlaryngoscopy and laterofixation of the vocal cord" could not be performed due to the malfunction.Change to surgery with co2 laser.The needle is very difficult to push out of the needle guide, therefore the surgeon has to apply high pressure.Furthermore, the locking of the holder does not work when the needle is retracted.A correct laterofixation could not be performed.Change to surgery with co2 laser.There was no danger to the patient or injury.

• Brand Name: NEEDLE PUSHER WL 210MM
• Common Device Name: NEEDLE PUSHER WL 210MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10073483
• Report Number: 9611102-2020-00006
• Device Sequence Number: 2911356
• Product Code: LRC
• UDI-Device Identifier: 04055207039199
• UDI-Public: 04055207039199
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 826750
• Device Catalogue Number: 826750
• Device Lot Number: 1019440
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other