MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK/E-LINE; ROUND BIPOLAR CUTTING ELECTRODE

Model Number 4622.1313

Device Problem Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/14/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(4) considers this mdr open.(b)(4) will submit a follow up report after the device evaluation has been completed and/or new information becomes available.We have sent the user facility a medwatch questionnaire for additional information about the patient and the original procedure in which the device presumably broke apart.

Event Description

It was reported to richard wolf by the user facility: patient presented (b)(6) 2021 in cystoscopy surgery with a free floating loop wire from the device in the report from a previous surgery with stone removal.It was unknown that the device had broken off from this prior surgery so neither container or device were retained at that time.Loop wire was removed, no patient harm was incurred; patient was notified.The loop wire will be retained by bristol hospital in our risk management department until further notice.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? n/a.Was the scheduled procedure completed? yes.This mdr is reporting the finding of the wire loop in the patient.I have reached out to the user facility both directly and indirectly to get the details about the stone removal procedure (where the wire loop came from).Once those details are known an mdr will be submitted.

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, and/or changed information.Rwmic considers this mdr open.Rwmic will submit another follow up report after the product history evaluation has been completed and/or new information becomes available.

Event Description

The purpose of this submission is to report the information received from the user facility.The original procedure ((b)(6) 2021), during which the wire loop was lost, was a cysto laser lithalopaxy.Description of the event or problem: "resectoscope loop was used during procedure.Patient returned for surgery on (b)(6) 2021.After insertion of scope, loop piece that had previously been used was found.".The user facility reconfirmed that the devices used during the 9/14/2021 procedure are not available for investigation.

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 #2 is to provide fda with new information.Rwmic considers this mdr closed.Rwmic will submit a follow up report if new information becomes available.

Event Description

The purpose of this submission is to report the results of the product history evaluation.The device was not returned to rw so an investigation report - product history evaluation was completed.Rw gmbh reports that: "in the past three years ((b)(6) 2018), richard wolf gmbh has received 5 complaints including the current complaint ((b)(4)) regarding the 46221313 cutting electrode bipo 24 fr 12/30° with various damages and causes outside the usa.However, there have been no complaints similar to those described above.Excessive force applied by the user may result in mechanical failure of the wire loop.Possible hazards are considered in the risk assessment bb2-3 rev.05 with corresponding extent of damage and probability of occurrence and are assessed with an acceptable risk.This assessment is still valid even taking into account the current case.".

• Brand Name: SHARK/E-LINE
• Type of Device: ROUND BIPOLAR CUTTING ELECTRODE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• MDR Report Key: 12609238
• MDR Text Key: 283409943
• Report Number: 1418479-2021-00046
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04055207048856
• UDI-Public: 04055207048856
• 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,health
• Type of Report: Initial,Followup,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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4622.1313
• Device Catalogue Number: 4622.1313
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2021
• Initial Date FDA Received: 10/11/2021
• Supplement Dates Manufacturer Received: 10/21/2021; 10/21/2021
• Supplement Dates FDA Received: 10/21/2021; 10/28/2021
• Patient Sequence Number: 1
• Treatment: LASER - LUMENIS; RESECTOSCOPE LOOP
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 78