MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK; INTERNAL SHEATH RESECTOSCOPE 24FR

Model Number 8675324

Device Problems Break (1069); Material Separation (1562)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2022

Event Type  malfunction  

Manufacturer Narrative

The instrument used was not sent to rw gmbh for examination.In addition, the user informed rw gmbh that the affected socket had already been scrapped.Consequently, the affected socket can no longer be examined, so no evaluations of the error pattern or conclusions about its cause can be made.The user manual ga-d366 / en / 2018-03 v5.0 / pk18-9297 contains the following applicable warnings for these errors: 7 application.Caution! limited stability of the products! excessive force applications cause damage, impair function and thus endanger the patient.Check products immediately before and after use for damage, loose parts and completeness.No missing parts may remain in the patient.Do not use products that are damaged, incomplete or have loose parts.7.3 hf application.Observe the "instructions for hf use", order no.Ga-s 002 and those of the hf device manufacturer.Must be observed.Warning! risk of injury if hf instrument is not in the surgeon's field of view! unintentional tissue damage as well as damage to the distal end of the endoscope and to the instrument parts is possible.Use hf instruments within the given specifications (dielectric strength, operating mode).Do not activate rf instruments until the part carrying the rf current appears fully in the field of view of the endoscope and the intended area of application is contacted.8 control.Caution! take care with damaged and incomplete products! injuries to the patient, user and third parties are possible.Perform checks before and after each application.Do not use products that are damaged, incomplete or have loose parts.Send damaged products with the loose parts for repair.Do not attempt to carry out repairs yourself.8.1 visual inspection.Check products and accessories for damage, sharp edges, loose or missing parts and rough surfaces.Pay particular attention to the insulation.Labels and markings required for safe and proper use must be legible.Missing, illegible inscriptions and markings that lead to errors in handling and reprocessing must be restored.Use new sterile electrodes.8.1.2 "shark" resectoscopes.Warning! risk of injury! improper handling, e.G., dropping, impact, shock or similar mechanical stress may result in hairline fracture and/or ceramic chipping in the distal area of the resectoscope shaft.Injuries to the patient, user and third parties are possible.Pay attention to surface changes and safe handling.Do not use the 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.Potential hazards have been considered in the d3 rev.04 risk assessment (reusable sheaths, tubes) with the corresponding extent of damage and probability of occurrence.Ceramic is a hard and therefore also brittle material and can therefore break abruptly if external loads are too high.However, it is very unlikely that such a tip will break off during use without prior damage.Pre-damage is most likely to occur during preparation, but is of course possible at many points before or after use.Improper handling, e.G.Dropping, impact, shock or similar mechanical stress can lead to hairline cracking and/or ceramic chipping in the distal area of the resectoscope shaft as described in the instructions for use.During subsequent use, even smaller forces are sufficient to damage the ceramic completely, as is most likely the case here.In the instructions for use, the user is advised to pay attention to surface changes and safe handling and not to use damaged resectoscope shafts and to send them in for repair.In this case, improper handling is indicated.It is expected that under close personal supervision of the patient during a procedure, missing parts will be discovered before the procedure is completed.Therefore, the likelihood that the reported problem will result in death, life-threatening injury, or permanent impairment of a body structure is low.The defects identified do not describe a general product problem involving non-conformity, negative trend or previously unknown hazards.Since the complaint relates to a handling error, a systemic problem is not apparent and the warnings according to the problem described by the customer in the operating manual ga-d366 / en / 2018-03 v5.0 / pk18-9297 are considered sufficient, no further action will be taken with regard to this incident, except for monitoring further cases to determine a possible trend.

Event Description

Richard wolf gmbh complaint reference: (b)(4).The user provided the following description of the incident: breaking off of the black plastic insulation during insertion (at the front of the resection shaft) into the bladder.This caused injury to the prostate and bleeding from the prostate.Due to the recovery and the exchange of the resectoscope shaft, the operation time was prolonged by about 15 minutes.The patient suffered an injury which had a regular course after hemostasis.Rwgmbh mdr awareness date: 29-oct-2022.

Event Description

Rwgmbh reference complaint no.(b)(4).The purpose of this submission is to provide a correction on g3: date received by manufacturer.See h10 for further explanation.

Manufacturer Narrative

Follow-up report #1 is to provide fda with the corrected and new information about this mdr.Corrected (awareness date): g3: (date received by manufacturer): (b)(6) 2023 rw gmbh has received first information without any device specifications and patient risk or harm on (b)(6) 2022, however the user facility has only confirmed the outcome of the adverse event on (b)(6) 2023.Therefore, the awareness date in the initial report was stated incorrectly.

• Brand Name: SHARK
• Type of Device: INTERNAL SHEATH RESECTOSCOPE 24FR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 2; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438, knittlingen, germany ; GM
• Manufacturer Contact: heiko seider-biedermann ; pforzheimer strasse 32; d-75438, knittlingen, germany ; GM
• MDR Report Key: 16235640
• MDR Text Key: 309159895
• Report Number: 9611102-2023-00002
• Device Sequence Number: 1
• Product Code: FJL
• UDI-Device Identifier: 04055207019658
• UDI-Public: 04055207019658
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

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
• Device Operator: Other
• Device Model Number: 8675324
• Device Catalogue Number: 8675324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2022
• Initial Date FDA Received: 01/24/2023
• Supplement Dates Manufacturer Received: 01/19/2023
• Supplement Dates FDA Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 84 KG