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

Model Number 8655.3841

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Rwmic considers this mdr/complaint open.Rwmic will submit a follow up report after the device evaluation has been completed and/or new information becomes available.

Event Description

Richard wolf received a medwatch report that stated: narrative from staff: "during the procedure, the end of the scope broke off and was discovered in the bladder at the end while morcellating the prostate chips." narrative from operative report: "beak of scope broke during the case and was in the bladder, this was removed with the morcellator-scope and a flexible scope.A 22fr 3-way catheter was placed with 20cc in balloon, continuous irrigation and patient returned to recover with clear urine." the device was received and sent to rw gmbh for evaluation.Preliminary evaluation: device complaint reported for 8654.3742, but is actually 8655.3841; adapter vs sheath in following up with the user facility: 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? no.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.

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Follow-up report #1 is to provide fda with new information (results of the device investigation), and any changed information.Changed information: the following fields have changed information: device labeling (ga-j020 and ga-d345) were reviewed for patient code and device codes, see below: 7 use.Caution! the products have only limited strength! excessive force will cause damage, impair the function and therefore en-danger the patient.Immediately before and after each use, check the products for damage, loose parts and completeness.Make sure that no missing parts remain in the patient.Do not use the products if they are damaged or incomplete or have loose parts.8 checks.Caution! be careful if products are damaged or incomplete.Injuries of the patient, user or 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.8.3 (reprocessing guide).Note: with various materials such as black anodized aluminum or plastic materials, severe discolorations can occur.This however does not imply functional impairment.6.2 cleaning.Important.Clean the instruments manually with care and thoroughly.Residues such as detergents, blood, pus, protein residues etc.Can impair an en­suing disinfection or sterilization.Note: lay down the instruments with care to avoid damage.Rwmic considers this mdr closed.Rwmic will submit a follow up report should new information become available.

Event Description

The purpose of this submission is to report the results of the device investigation.According to the device investigation, rw gmbh visually inspected the device and according to them: "the inner sheath show clear signs of intensive use: - laser marking (batch and material numbers) are worn off; - clear scratches on the surface of the inner sheath; - inner sheath is bent; - color of the plastic part is bleached.The tip of the inner sheath was broken due to mechanical overload such as a fall.The tip fo the inner sheath includes material zirkondioxid zr02 (3y-tzp0 bk, this ceramic like material is sensitive and brittle with less flexibility.Due to intensive use, careless handling (such as shocks) and aggressive cleaning, the useful life of this device can be shortened." the probable root cause is user error.The inner sheath 8655.3841 was produced in 2005.There were no issues found with the resectoscope that was sent in with the above device.

• Brand Name: E-LINE
• Type of Device: INTERNAL SHEATH RESECTOSCOPE 26FR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 11728915
• MDR Text Key: 267299400
• Report Number: 1418479-2021-00015
• Device Sequence Number: 1
• Product Code: FDC
• UDI-Device Identifier: 04055207028094
• UDI-Public: 04055207028094
• Combination Product (y/n): Y
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

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: M681450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/26/2021
• Supplement Dates Manufacturer Received: 10/13/2021
• Supplement Dates FDA Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8654.3742, CONNECTING PART RESECTOSCOPE 24FR
• Patient Age: 63 YR
• Patient Weight: 87