MAUDE Adverse Event Report: RICHARD WOLF GMBH E-LINE INTERNAL SHEATH RESECTOSCOPE 26FR; RESECTOSCOPE, WORKING ELEMENT

Model Number 8655.3841

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 04/14/2020

Event Type  malfunction  

Manufacturer Narrative

Instrument was not available for inspection due to the existing damage pattern.It must be assumed that the insulating insert has already been damaged, e.G.During preparation or transport.Such mechanical pre-damage, in connection with the formation of the smallest stress cracks or hairline cracks within the ceramic, can in these cases lead to a possible breakage of the ceramic and the associated loss of parts when using the product.In the ga-d345 instructions for use, chapter 8.1.2, a warning is given regarding the necessary visual checks before each application: improper handling, e.G.Falling, impact, shock or similar mechanical loads can lead to hairline cracks and/or ceramic chipping in the distal area of the resectoscope shaft.Injuries to the patient, user and third parties are possible.Do not use damaged resectoscope shaft and send it in for repair.Check the ceramic insulation at the distal end of the resectoscope shaft for damage before each use.A breakage of the missing ceramic insulation tip is not expected under normal conditions of use and when used as intended.Possible hazards were considered in the risk assessment d3 rev.03 (reusable shanks and tubes) with the corresponding extent of damage and probability of occurrence.From our point of view, this is a user error, as the visual and functional checks were not or only partially carried out.Rw (b)(4) considers this report closed.If any additional information is obtained, a follow up report will be submitted to the fda.(b)(4).

Event Description

Rw (b)(4) was notified by their distributor for the following product problem: it was reported that the patient was taken to the recovery room after bladder tumor resectoscope procedure.The cleaning staff then found sheath ceramic head was missing.They looked for clothes and garbage room but could not find the missing ceramic head.Immediately they reported to the head nurse, informed the surgeon to carry out an examination with ultrasound in the patient's bladder but did not found any foreign body.Then, they decided to perform cystoscopy and found the missing head inside bladder, using forceps they were able to remove it from patient.

• Brand Name: E-LINE INTERNAL SHEATH RESECTOSCOPE 26FR
• Type of Device: RESECTOSCOPE, WORKING ELEMENT
• 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: 10652681
• MDR Text Key: 242908764
• Report Number: 9611102-2020-00021
• Device Sequence Number: 1
• Product Code: FDC
• UDI-Device Identifier: 04055207028094
• UDI-Public: 04055207028094
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8655.3841
• Device Catalogue Number: 8655.3841
• Device Lot Number: 1361850
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 10/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2007
• 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