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

Model Number 826750

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2020

Event Type  malfunction  

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 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
• Type of Device: NEEDLE PUSHER WL 210MM
• 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: 10073483
• MDR Text Key: 229567810
• Report Number: 9611102-2020-00006
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 04055207039199
• UDI-Public: 04055207039199
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 826750
• Device Catalogue Number: 826750
• Device Lot Number: 1019440
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2007
• 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