MAUDE Adverse Event Report: RICHARD WOLF GMBH; INNER SHEATH RESECTOSCOPE 22FR

Model Number	86753225
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Rwmic reference complaint no.(b)(4).On (b)(6) 2022, it was reported to richard wolf medical instruments corp.(rwmic) by a user facility representative that product id# 86753225 lot 1498308 sheath has a broken beak.The beak broke off inside patient.All pieces were retrieved.Initial information reported by the user facility representative: (email, dated august 5, 2022) "a person just brought me the 86753225 lot 1498308 sheath with the broken beak.He reported the piece broke off inside the patient.It was retrieved and is in the package with the broken sheath." will the device be returned? yes.Was the device being used on a patient when the reporting issue occurred? yes.Was there any injury or illness to the patient due to the reported issue? no.Was there any injury or illness to any other personnel due to the reported issue? no.Did the issue cause a delay in the procedure being performed? yes.Did the delay put the patient at risk? no.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.On 22-aug- 2022, additional information's were provided by the initial reporter: how long was the procedure delayed? 10 min.What actions were being done during the delay? pulled a back up tray.Did the patient require any additional treatment during the delay or will require.Another procedure as the result of the delay? no.What was the patient's outcome? finished the case.Rwmic mdr awareness date: 10-aug-2022.Also, the purpose of this submission is to provide the results of the device investigation.
Additional Manufacturer Narrative
Richard wolf medical instruments corporation is the importer of this device.Rwmic is submitting this report on behalf of richard wolf gmbh (manufacturer).Device investigation results: rwmic investigation report device evaluation, form 5020 (12) the device was tested visually and mechanically.The reported condition was confirmed and the device did not meet specifications.The evaluation found that the damage is consistent with an impact against a hard surface.Damage may have caused a thin fracture that held together until there was stress on the device during use instead of breaking apart immediately.The instruction manual ga-d366-us / en / 2017-02 v4.0 / eco 2016-0202 contains the following applicable warnings for these faults: 8 checks caution! be careful if products are damaged or incomplete! injuries of the patient, user and others are possible.Run through the checks before and after each use.Do not use the products if they are damaged, incomplete or have loose parts.Return damaged products together with any loose parts for repair.Do not attempt to do any repairs yourself.8.1 visual check check products and accessories for damage, sharp edges, lose or missing parts and rough surfaces.Check the insulation with particular care.Any lettering, labeling or identification necessary for the safe intended use must be legible.To prevent wrong handling or reprocessing, any illegible lettering, labeling or identification must be reinstated.Use new sterile electrodes.8.1.2 "shark" resectoscope warning! danger of injury! incorrect handling, e.G.Fall, shock, blows or similar mechanical loads can cause hair cracks and / or spalling of the ceramic coating in the distal area of the resectoscope sheath.Injuries of the patient, user or third parties are possible.Mind surface changes and ensure safe handling.Do not use damaged resectoscope sheaths, return damaged sheaths for repair.Check the ceramic insulation at the distal end of the resectoscope sheath for damage before every use.9.4 reprocessing procedure important! if the instrument is used as intended and provided that the manufacturer's manual is followed, it is not necessary to limit the number of possible reprocessing cycles.Careful and gentle handling of medical products during the entire reprocessing process has an essential influence on the service life of the products.Before returning defective products for repair, they must have been subjected to the entire reprocessing cycle.The user must ensure that the reprocessing process including the resources, materials and personnel are suitable to achieve the required results.Comply with the national and international requirements regarding the validation of the user's reprocessing process.Important! do not sterilize the products in hot-air sterilizers.Additionally, on august 23, 2022, a follow-up email was sent to the user facility together with the sales representative regarding the patient information.However, no further information is available at this time.(email reply, 8/24/2022) rw considers this matter closed.However, if a new information becomes available, rw will submit a follow-up report.

• Brand Name: NA
• Common Device Name: INNER SHEATH RESECTOSCOPE 22FR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; 75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer Contact: zsófia bartholome-nagy ; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• MDR Report Key: 15294807
• Report Number: 9611102-2022-00041
• Device Sequence Number: 11450045
• Product Code: FJL
• UDI-Device Identifier: 04055207065464
• UDI-Public: 04055207065464
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Inspection,Repair
• Type of Report: Initial
• Report Date (Section B): 08/25/2022

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?: Yes
• Device Model Number: 86753225
• Device Catalogue Number: 86753225
• Device Lot Number: 1498308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown