MAUDE Adverse Event Report: RICHARD WOLF GMBH E-LINE CONNECTING PART RESECTOSCOPE REUSABLE

Model Number 8654.3742

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Ifu was reviewed, see below: caution! the products have only limited strength! 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.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.Caution! be careful! [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.Warning! danger of injury! wrong handling, e.G.If dropped, impacted or damaged by similar mechanical loads can cause hair cracks and/or "spaiing" of ceramic material in the distal area of the resectoscope sheath.Injuries to 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.Rwmic considers this case open.A follow up report will be submitted upon receipt of new or additional information.

Event Description

On april 19, 2019 the user facility reported the following to richard wolf medical instruments corporation (rwmic): an incident did occur on a patient during the case.The case finally started 75mins delayed and the doctor used the wolf piranha green light laser tray for approximately 1hr 45mins using 338,167 joules scope set worked extremely well with 26fr outer sheath and 24fr inner sheath but when it was time to switch to morcellator part of the case the doctor notice an object in the bladder and used a grasper to retrieve the object.The object was a piece of broken off debris from the distal tip of the 24fr inner laser sheath.The doctors technique was very good so i did not notice any mishandling of the equipment.I notified the operating room charge nurse, ms.(b)(6) of the damage which occured to the wolf 24fr inner sheath and that they would be liable for the cost of repair.The case was completed without injury to the patient or staff.Will the device be returned? yes.Was the device being used during a procedure when the issue occurred? yes.Specifically, was the device being used on a patient when the issue occurred? yes.Was there any injury or illness to patient or other personnel due to issue? no.Did the issue cause a delay in the procedure being performed that put the patient at risk? no was there.A similar back-up device available for use? unknown.Was the scheduled procedure completed? yes.How was the patient anesthetized? unknown.User facility returned the device to rwmic on april 24, 2019, and the evaluation was completed on may 08, 2019.The device appeared to be used and the complaint conditions could not be verified.After performing functional testing it was found that the probable root cause is normal wear and tear.A manufacturing defect was not identified so the complaint is not considered valid.

• Brand Name: E-LINE CONNECTING PART RESECTOSCOPE REUSABLE
• Type of Device: CONNECTING PART RESECTOSCOPE REUSABLE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: oliver ehrlich ; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 8621180
• MDR Text Key: 155817640
• Report Number: 1418479-2019-00020
• Device Sequence Number: 1
• Product Code: FDC
• UDI-Device Identifier: 04055207028049
• UDI-Public: 04055207028049
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/17/2019,04/19/2019

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: 8654.3742
• Device Catalogue Number: 8654.3742
• Device Lot Number: 1329503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2019
• Distributor Facility Aware Date: 04/19/2019
• Date Report to Manufacturer: 05/17/2019
• Initial Date Manufacturer Received: 04/24/2019
• Initial Date FDA Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention