MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK; CUTTING ELECTRODE MONO 22FR

Model Number 46782225

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/31/2020

Event Type  malfunction  

Manufacturer Narrative

Rwmic will reach out to the user facility and the manufacturer to gather additional information.Upon receipt of new information, a follow-up report will be submitted.

Event Description

It was reported by the user facility ((b)(6) 2020) that while resecting tissue the first loop broke, and the same while using the second but the loop broke completely off into the patient.Will the device be returned? no.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.

Event Description

Rwmic reached out to the initial reporter to request additional information.On (b)(6) 2020 the initial reporter provided new information.This follow up report is initiated to record the additional information received from the user facility.

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 reached out to the initial reporter to request additional information.On (b)(6) 2020 the initial reporter provided new information.A review of the manual for universal nephroscopes, ga-d366 contains the following applicable warnings according to this error: 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! do not combine products incorrectly! injuries of the patient, user or others as well as damage to the product are possible.The different products may only be used together if their intended uses and the relevant technical data (working length, diameter, peak voltage, etc.) are the same.Follow the instruction manuals of the products used in combination with this product.Follow the "notes and instructions on hf applications", order no.: ga-s 002 as well as the hf device manufacturer's instructions.Warning! danger of electric shock! patient leakage currents can add up if the endoscopes are combined with other powered endoscopic accessories.Make sure that the combinations do not exceed the permissible patient leakage currents.At this time, rwmic considers this mdr/complaint closed.However, in the event that additional information become available a follow up report will be submitted.

• Brand Name: SHARK
• Type of Device: CUTTING ELECTRODE MONO 22FR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10408298
• MDR Text Key: 204418796
• Report Number: 1418479-2020-00021
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04055207049020
• UDI-Public: 04055207049020
• Combination Product (y/n): N
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/13/2020,11/24/2020

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: 46782225
• Device Catalogue Number: 46782225
• Device Lot Number: 21002035
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/13/2020
• Distributor Facility Aware Date: 08/03/2020
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2020
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 08/14/2020
• Supplement Dates Manufacturer Received: 08/13/2020
• Supplement Dates FDA Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 82