MAUDE Adverse Event Report: RICHARD WOLF GMBH HF CONNECTION CABLE

Model Number 8106.033

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Rwmic will collect additional information from the manufacturer and the user facility.Upon receipt of such information rwmic will submit a follow up report as appropriate.Rwmic considers this case open.

Event Description

Richard wolf medical instruments corporation, hereinafter referred to as rwmic, was notified on an event that occurred at the user facility, on an unspecified date, during patient procedure.The customer reported: "the handpiece with the cord caught on fire during a case, cutting the cord connector from the ufp connector." the procedure was completed as scheduled and there was no patient injury as a consequence of this event.

Manufacturer Narrative

Follow-up report #1 is to provide fda with new and changed information.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, see below: warning! hf cables with defective, brittle or cracked insulation can cause burns to the user or patient.If the electrical line breaks, an arc can occur causing burns to the user or patient or start a fire, regardless of whether the insulation is also damaged or not.Never use or repair defective hf cables! always replace them.Do not modify hf cables! the uni/monopolar cables may be operated at a maximum recurrent peak voltage of 4000 vp and the bipolar cables at max.1000 vp.Important! when plugging and unplugging the hf cable, always hold the plug, never pull the hf cable.Do not place hf cables in parallel with other signal lines (e.G.Camera cable) tominimize the danger of interference from hf radiation.Richard wolf medical instruments corporation (rwmic) considers this case closed.In the event that rwmic receives additional information a follow up report will be submitted to the fda.

Event Description

Follow-up report #1 is to provide fda with new and changed information.User facility returned the device to rwmic on august 15, 2018, and the evaluation was completed on april 02, 2019.The cable was inspected and the cable was found to be broken.The root cause of the device failure was determined to be wear and tear.The cause for the wire breakage is the use of the cable up to the absolute wear/ failure.

• Brand Name: HF CONNECTION CABLE
• Type of Device: HF CONNECTION CABLE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, gm 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, gm 75438 ; GM 75438
• Manufacturer Contact: oliver ehrlich ; heinrich-hertz-strasse 4-10; gomaringen, 72810 ; GM 72810
• MDR Report Key: 7858127
• MDR Text Key: 119634968
• Report Number: 1418479-2018-00028
• Device Sequence Number: 1
• Product Code: FKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/02/2019,09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8106.033
• Device Catalogue Number: 8106.033
• Device Lot Number: 4-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/02/2019
• Distributor Facility Aware Date: 04/02/2019
• Device Age: 18 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2019
• Date Manufacturer Received: 04/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2001
• 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
• Patient Outcome(s): Other