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

Model Number 8108232

Device Problem Sparking (2595)

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

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

Rwmic will follow up with the user facility and manufacturer to obtain additional and missing information.

Event Description

The user facility reported to richard wolf medical instruments (rw mic) that on (b)(6) 2020, a cable sparked during a case.There was no patient injury.

Event Description

User facility returned the device to rwmic on october 6, 2020, and the evaluation was completed on october 22, 2020: the reported condition was verified using visual and mechanical testing.It was determined that the cable seems to be worn from wear and tear, strains appear to be broken due to fatigue causing spark.The root cause was determined to be normal wear and tear.The device does not meet the specifications therefore product disposition is determined to be scrap.

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Label review (ga- as002-usa).Caution! be careful if products are incorrectly combined! injury may result to the patient, user or others and damage may result to the product.Different products should only be used in combination if their intended uses and relevant technical data (working length, diameter, peak voltage, etc.) are the same.Follow the instruction manuals of the products used in combination with this product.Note! check that the line voltage is the same as the voltage specified on the identification plate.Connect the device only with the supplied power cable or a power cable meeting the same specifications.Important! carry out checks before and after each use.Do not use products once they are damaged, incomplete or have loose parts.Return damaged products with the loose parts for repair.Do not attempt to do any repairs yourself.Caution! the products have only limited strength ! exerting 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.Ensure that no missing instrument parts remain in the patient.Do not use products which are damaged, incomplete or have loose parts.Danger of burns! hf connection cables with defective or cracked insulation or inadvertent parting of the connector and contact of the latter with bare metal parts such as the operating table, supporting arms, etc.Can lead to burns to the user or patient or cause fires.Make sure that the connector of the hf cable is securely connected, and do not use defective hf connection cables.Do not repair such cables, replace cables instead.By no means must the hf connection be modified.Use the hf bipolar connection cable (14) only at a maximum recurring peak voltage of up to 1000 vp.Rwmic considers this mdr/complaint open.Rwmic will contact the user facility for missing patient information.

Event Description

The follow up #2 is to report the patient information and additional information received from the initial reporter.

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.On (b)(6) 2021, rwmic received new information from the initial reporter.Rwmic consider this mdr and complaint closed at this time.If additional information become available, a follow up report will be submitted.

• Brand Name: SHARK/S-LINE
• Type of Device: HF BIPOLAR CONNECTING CABLE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10599616
• MDR Text Key: 208950569
• Report Number: 1418479-2020-00028
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04055207000908
• UDI-Public: 04055207000908
• Combination Product (y/n): N
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2021

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: 8108232
• Device Catalogue Number: 8108.232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 09/24/2020; 09/24/2020
• Supplement Dates FDA Received: 11/03/2020; 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR