MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK/S-LINE; HF BIPOLAR CONNECTING CABLE

Model Number 8108.232

Device Problems Material Separation (1562); Sparking (2595)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2022

Event Type  malfunction  

Event Description

Rw mic received a medwatch report from the fda on march 3, 2022.It was reported that "during transurethral resection of prostate, r.Wolf bipolar cord (8108232) sparked/exploded off instrument while in use (bipolar turp setting preset).Fda safety report id# (b)(4).".

Manufacturer Narrative

Rwmic considers this mdr open.Rwmic will submit a follow up report after the device investigation and/or product history evaluation has been completed and/or new information becomes available.We've attempted to contact the user facility for additional information but have gotten no response as of 4/1/2022.

Manufacturer Narrative

Follow-up report #1 is to provide fda with new and corrected information about this mdr.The results of the due diligence for patient informations: rwmic have contacted the user facility on three (3) occasions requesting for patient informations that were not provided during the initial report submission.There was no response received from the complainant as of today, 09/15/2022.Dates of contact: 1st attempt: 04/01/2022 - via email, no response.2nd attempt: 04/18/2022 - via email, no response.3rd attempt: 08/08/2022 - via email, no response device return status: device has not been returned.In lieu of the device not being returned, rwmic issued a request to richard wolf gmbh (manufacturer) for a device product history evaluation to be performed.Form 5253 (00), date: 9/1/2022.The results of the device product history evaluation: form 5253 (00) the batch number of the reported bipolar cord 8108.232 is unknown, so it is not possible to review the device history records.The user facility has reported that the cord sparked/exploded off instrument while in use, however the user facility confirmed that the reported cord won't be returned for investigation, the exact root cause could not be determined.Previous complaints: furthermore, the user is advised in the relevant ifu ga--as 002--usa / en / index: 02--06--3.0 / am: pdg 06--1305 about the checks of the cord before and after each use in section 4 checks as well as about the maintenance interval in section 6.5.1 maintenance intervals.Rwgmbh has received 3 complaints including the current complaint (b)(4) regarding the bipolar cord 8108.232 between 01/01/2019 and 09/02/2022.The devices from the previous complaints were returned for investigation: 700013994 - recorded on 01/31/2020; the cord is not recognized by the hf generator; sporadic failure of the cord; no patient involvement was reported 700014535 - recorded on 06/10/2020; the plug on the proximal side is electrically burnt/fused; cleaning / maintenance failure; no patient involvement was reported there was 1 complaint (b)(4) which was not returned to rw gmbh for investigation.Richard wolf medical instruments corporation (rwmic) considers this mdr closed.Rwmic will submit a follow up report when new information becomes available.

Event Description

Rwmic reference complaint no.(b)(4).The purpose of this submission is to report the results of the device product history evaluation, as well as due diligence inquiry for patient information.

• Brand Name: SHARK/S-LINE
• Type of Device: HF BIPOLAR CONNECTING CABLE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• MDR Report Key: 13978380
• MDR Text Key: 293086633
• Report Number: 1418479-2022-00010
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04055207000908
• UDI-Public: 04055207000908
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 09/16/2022

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: 8108.232
• Device Catalogue Number: 8108.232
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/16/2022
• Distributor Facility Aware Date: 03/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NOT REPORTED - UNKNOWN
• Patient Outcome(s): Other