MAUDE Adverse Event Report: RICHARD WOLF GMBH S-LINE; WORKING ELEMENT PASSIVE BIPO 0/12/30°

Model Number 8680225

Device Problems Overheating of Device (1437); Smoking (1585); Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 10/17/2023

Event Type  malfunction  

Event Description

The user facility has informed richard wolf gmbh of an issue regarding a working element passive bipo 0/12/30°, part id: 8680.225, lot # 1499179.According to the received information, the working element overheated and has burn marks on it.The working element passed current to the physician and then smoked.There is no report of injury to the patient or other personnel.However, the reported issue caused a 15-20 minute delay mid-case to retrieve a back-up device.The scheduled procedure was completed.

Manufacturer Narrative

The following fields have new information: b4, g3, g6, h2, h3, h6 (type of investigation, investigation findings, and investigation conclusions), and h10.The working element passive bipo 0/12/30°, part id: 8680.225, lot # 1499179 was investigated at richard wolf medical instruments, corp (rwmic).The investigation findings confirmed presence of severe burn marks inside the guide shaft.The darkening of metal is consistent with extreme heat exposure along surface of shaft near electrical connections.However, all electrical functions are within tolerance of the test procedure document tp-016 rev 02.Additional findings showed severe corrosion and burn marks on the internal contacts with electrode.Therefore, device is no longer reliably safe for use.Further investigations revealed that the damage is most consistent with attempted use of instrument while damp with saline.High voltage current across saline can rapidly corrode metal and produce shorts and extreme heat.Therefore, reprocessing error and user error has been determined to be the probable root cause of the reported event.The working element passive bipo 0/12/30°, part id: 8680.225, lot # 1499179, was produced on 26/nov/2021 with a batch size of 35 units.The examination of the production documents did not reveal any anomalies or deviations in the serial number.A review of the last 2 years has shown that there are a total of 7 complaints from different batches and only one complaint with a similar allegation.Due to it, a systematic error cannot be deduced from this data.In general, the user is advised in the associated instructions for use, ifu ga-d342 / en / 2021-03 v16.0 / pk20-0295, under chapter 7.2.2 warning: risk of burns! risk of electric shock! unintended loosening of the plug connections and their contact with bare metal parts, e.G., operating table, support arms, etc.During hf application may lead to skin burns for the patient or user.Also, chapter 9.4.2 reprocessing and maintenance emphasizes the proper handling of the working element during machine cleaning.In order to avoid such damages, chapter 8, recommends that a visual and functional check must be carried out before and after each use, among other things with regard to the hf bipolar connection cable in connection with the saline resectoscope and the hf surgical device.The subject issue of burns of the devices is present in the risk management file b6 - reusable optical working inserts, rev.04.The overall probability of occurrence for this issue remains are previously defined levels and overall risk of the device remains in the acceptable category.

• Brand Name: S-LINE
• Type of Device: WORKING ELEMENT PASSIVE BIPO 0/12/30°
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: valentin felsing ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 18100483
• MDR Text Key: 329126327
• Report Number: 9611102-2023-00065
• Device Sequence Number: 1
• Product Code: FDC
• UDI-Device Identifier: 04055207042953
• UDI-Public: 04055207042953
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

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: 8680225
• Device Catalogue Number: 8680.225
• Device Lot Number: 1499179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 11/20/2023
• Supplement Dates FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1