MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK/S-LINE; CUTTING ELECTRODE BIPO 22 FR

Model Number 46221333

Device Problem Material Fragmentation (1261)

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

Event Type  malfunction  

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf (b)(4).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, the user facility has been contacted and/or new information becomes available.

Event Description

It was reported to richard wolf by the user facility that "during an operative hysteroscopy the bipolar loop broke off into the patient.Per the customer, they do not have the item, it was thrown out." additional information: 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? no.Did the delay put the patient at risk? n/a.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.

Manufacturer Narrative

Follow-up report #1 is to provide fda with missing information, new information, and changed information.Missing information: user facility was contacted for additional information (patient details, procedure type, etc), response was that no addition information was available.Device labeling was reviewed for patient code and device codes, see below: warnings and cautions: caution! do not combine products incorrectly! injuries of the patient, user or others as well as damage to the product are possible.Joint use of the different products is only allowed if the intended uses and relevant technical data (such as working length, diameter, peak voltage, etc.) are the same.Follow the instruction manuals of the products used in conjunction with this product.Also follow the "instructions on hf applications", order no.: ga-s 002 as well as the hf device manufacturer's instructions.6 use: caution! the products have only limited strength! excessive force will cause damage, impairs the function and therefore endangers 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.6.2.4 hf applications: caution! careful if the hf voltage/power is set too high! danger of injury resulting from damage to the electrode insulation! damaged insulation can cause leakage currents.Thermal damage to the patient and/or user are possible.Replace electrode.Caution! thermal damage may be caused if the vaporization electrode is permanently activated! high levels of heat or distal wear to the electrode insulation may be the result.Note: excessive power settings can cause clearly increased electrode wear.We recommend starting at a lower power setting to determine the optimum power setting.7.0 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.7.1 visual checks: check the products and the accessories for: damage; sharp edges; loose or missing parts; rough surfaces; check the insulation with particular care.Rw considers this case closed.Should additional information become available a follow up report will be submitted.

Event Description

The purpose of this submission is to report the results of the device investigation and contact with the user facility.For the device evaluation: the device was returned to richard wolf on 8/17/2021 and visually inspected.Findings: base of loop may have been bent at some point, weakening the wire and causing it to burn through at bend and /or break off when pressure was applied during the procedure.Specific cause cannot be determined without information from procedure (was electrode unpacked and installed correctly).Was voltage set to optimal level, etc.).Root cause indeterminate.The reported condition by user facility was confirmed.The device was scrapped.Note: originally the device was not going to be returned, on 7/27/2021 rw received notice that the device was found and was being sent in for evaluation.

• Brand Name: SHARK/S-LINE
• Type of Device: CUTTING ELECTRODE BIPO 22 FR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 12158888
• MDR Text Key: 274083900
• Report Number: 1418479-2021-00032
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04055207048870
• UDI-Public: 04055207048870
• Combination Product (y/n): N
• PMA/PMN Number: K060720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 46221333
• Device Catalogue Number: 4622.1333
• Device Lot Number: 1445943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Date Manufacturer Received: 09/13/2021
• Patient Sequence Number: 1