MAUDE Adverse Event Report: RICHARD WOLF GMBH SHEATH FOR E-LINE CYSTOSCOPE 21FR

Model Number	86500.445
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	10/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following checks, cautions, and warnings are outlined in the information for use (ifu): 6.Use caution! the products have only limited strength! exerting excessive force will cause damage, impair the function and therefore endanger the patient.Immediately before and after each use, check the products for damage, loose parts and completeness.Ensure that no missing instrument parts remain in the patient.Do not use products which are damaged, incomplete or have loose parts.7 checks - caution! be careful if products are damaged or incomplete.Possible injury of patient, user or third persons.Run through the checks before and after each use.Do not use products which are damaged or incomplete or have loose parts.Return damaged products together with loose parts for repair.Do not attempt to do any repairs yourself.7.1 visual check - before and after each use check instruments and accessories for damage, sharp edges, loose or missing parts and rough surfaces.Any lettering, labelling and identification necessary for the safe intended use must be legible.Missing or illegible lettering, labelling and identifications which may lead to wrong handling or reprocessing must be restored or the parts discarded.Check all connection cables, tubes and connectors for damage.Replace damaged and brittle rubber caps.This case is considered closed.Should additional information become available, a follow up report will be submitted.
Event or Problem Description
On 31 october 2019, richard wolf (b)(4) received the following information: the customer informed by telephone that damage to the patient has occurred due to the use of the instrument within the scope of an operation.The shaft for cystoscope 21ch, type 86500445 is said to have had a burr, resulting in a perforation on the patient.Detailed written information about the event or the patient injury damage was not provided.The device was returned to the manufacturer for evaluation.It was found that the device shaft shows only slight signs of wear: no dents on the outer wall of the shaft tube the shaft tube is not bent.Sheath tube diameter and mounting hole in the rotating locking part are dimensionally accurate - no tolerance deviation verifiable.Distal end is burr-free and sufficiently rounded.The laser marking on the product is still clearly legible.The brass flushing taps located on the rotary plug are still completely functional.Adhesive connection on the screw cap of the drain cock is coming loose on one side.There were no signs of improper use noted.The chromium-plated brass flush taps and the batch numbers indicate the instrument had been in use for some time (approximately 14 years).A search of the complaints database was undertaken for the period 01/01/2015 to 10/31/2019.During this period, there were no similar cases.A product defect trend is not discernible.In the risk assessment d3 rev 02, the present complaint case is assigned to (b)(4) and thus to the hazard due to mechanical energy resulting from a handling issue.Except for normal traces of use on the product, no damage can be detected.The distal shaft window is burr-free and sufficiently rounded.The customer's complaint cannot be reconciled to the instrument investigated product.

• Brand Name: SHEATH FOR E-LINE CYSTOSCOPE 21FR
• Common Device Name: SHEATH FOR E-LINE CYSTOSCOPE 21FR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 9583472
• Report Number: 9611102-2019-00036
• Device Sequence Number: 13567605
• Product Code: FDC
• UDI-Device Identifier: 04055207027899
• UDI-Public: 04055207027899
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K062720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 86500.445
• Device Catalogue Number: 86500.445
• Device Lot Number: M577810
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 01/13/2020
• 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: Hospitalization