MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, MONOPOLAR, 3.5 M; ELECTRICAL-ONLY MEDICAL DEVICE CONNECTION CABLE, REUSABLE

Model Number A0336.1

Device Problems Melted (1385); Flare or Flash (2942)

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

Event Date 11/16/2018

Event Type  malfunction  

Manufacturer Narrative

The reported cable device was not returned to olympus for evaluation.The cause of the reported complaint cannot be confirmed.Despite several followup attempts, there is no further information regarding the procedure, the location of reported burning / melting on the device, the service age of the device, or the handpiece involved.As preventive measures, the cable instructions state, ¿do not use the hf cable after one year of use.¿ ¿visually inspect the cable and the plugs for irregularities on the surface.¿ and ¿do not use a cable with brittle or defective insulation.Replace the cable.¿ the instructions also warn, ¿use only compatible equipment¿ listed in the instructions, and ¿the maximum output voltage of the hf unit must not exceed the lowest maximum rated voltage of any of the hf components used during the procedure.¿ the user facility was also advised of the one year maximum usage recommendation at the time that the event was reported to olympus.

Event Description

Olympus was informed that at the end of an unspecified procedure, the cord had a flame and melted.There was no reported injury to the patient or to any other person.It was reported that the procedure was completed successfully since the event occurred at the end of the procedure.

• Brand Name: HF-CABLE, MONOPOLAR, 3.5 M
• Type of Device: ELECTRICAL-ONLY MEDICAL DEVICE CONNECTION CABLE, REUSABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8143635
• MDR Text Key: 130030447
• Report Number: 2951238-2018-00746
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761001472
• UDI-Public: 04042761001472
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951863
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2018

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: A0336.1
• Device Catalogue Number: A0336.1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2018
• Initial Date FDA Received: 12/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1