MAUDE Adverse Event Report: RICHARD WOLF GMBH E-LINE; CUTTING ELECTRODE

Model Number 8424.141

Device Problem Material Fragmentation (1261)

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

Event Date 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

User facility and manufacturer to be contacted to obtain additional information.Should additional information become available, a follow-up report will be submitted.

Event Description

The user facility reported that the wolf cutting loop during cysto turp broke during use.Loose piece was retrieved, no harm to patient.

Event Description

Follow up report #1 is to provide fda with additional information.Refer to manufacturer narrative for details.

Manufacturer Narrative

Follow-up report #1 is to provide fda with additional information.The following fields have additional or new information : b5, f3-5, f7, f9, g7, h1, h2, h3, h4, h6 and h10.The initial reporter confirmed that the device was discarded and would not be returned for evaluation.However, rwmic investigated this case by reviewing the previous complaint data and labeling information.There are no previous complaints received in the past year for the same or similar issue.Device labeling was reviewed for patient code and device codes, see below: patient code: not applicable, no patient problem was reported.Device code: ifu was reviewed.Ifu includes the following warnings: 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 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.Caution! no excessive power settings in the areas of the sphincter and cervix! excessive power settings in these areas can cause thermal damage and lead to a dysfunction of the sphincter or cervix.An indicator for an excessively high power setting is a discoloration of the tissue to brown or black, or carbonization, respectively.Depending on the power / mode of the electrode, the depth effect (necrosis) is approx.0.5 to 2 mm in the area of the sphincter and cervix.It is therefore essential to work with particular care and the lowest possible hf output we recommend the following power settings: reprocessable electrodes, sterile electrodes, discardable (for single use) cutting mode: 120 - 180 watts; coagulation mode: max.100 watts; evap electrodes; cutting mode (vaporization): 200 - 230 watts; coagulation mode: max.100 watts; spray coagulation is not allowed for continuous- irrigation double-sheaths with window.At this time, rwmic considers this matter closed.However, in the event rwmic receives additional infromation a follow up report will be submitted to fda.Attachment: [ga-d345 usa_4.0 (11-0484).Pdf].

• Brand Name: E-LINE
• Type of Device: CUTTING ELECTRODE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10356566
• MDR Text Key: 201837700
• Report Number: 1418479-2020-00019
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04055207017227
• UDI-Public: 04055207017227
• Combination Product (y/n): N
• PMA/PMN Number: K980302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/03/2020

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: 8424.141
• Device Catalogue Number: 8424.141
• Device Lot Number: 51001384
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/03/2020
• Distributor Facility Aware Date: 07/27/2020
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2020
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/03/2020
• Supplement Dates Manufacturer Received: 08/03/2020
• Supplement Dates FDA Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 54