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

Model Number	8655.3841
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/14/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: RESECTOSCOPE, WORKING ELEMENT
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10652681
• Report Number: 9611102-2020-00021
• Device Sequence Number: 11504090
• Product Code: FDC
• UDI-Device Identifier: 04055207028094
• UDI-Public: 04055207028094
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 8655.3841
• Device Catalogue Number: 8655.3841
• Device Lot Number: 1361850
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1