MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, MONOPOLAR, 3.5 M, UES-30,; HF CABLE

Model Number A0358

Device Problem Arcing (2583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of the reported event could not be determined; however, the instruction manual contains warning statements in an effort to prevent sparking and patient injury."before use, make sure that the product has been properly reprocessed, inspected, and tested.Improper use of hf current can cause endogenous or exogenous burns, and explosions.Risk of death or serious injury may occur.".

Event Description

Olympus was informed that at the start of an unspecified procedure, the high frequency (hf) cable sparked on the generator connecting end.There was no patient or user injury reported.No fire emergency evacuation took place.The generator was a non olympus device (valley lab).The cable was replaced and the procedure was successfully completed.

• Brand Name: HF-CABLE, MONOPOLAR, 3.5 M, UES-30,
• Type of Device: HF CABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: donny shapiro ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-516
• MDR Report Key: 5748259
• MDR Text Key: 48138254
• Report Number: 2951238-2016-00533
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK944201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/24/2016

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: A0358
• Device Catalogue Number: A0358
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 06/03/2016
• Initial Date FDA Received: 06/24/2016
• 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