MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH WORKING ELEMENT, PASSIVE

Model Number WA22067A

Device Problems Charred (1086); Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2017

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report was returned to olympus for evaluation.A visual inspection of the device found charred deposits inside the distal opening of the teflon body.An olympus test electrode was inserted to the device but would not lock into position.The hf connector was disassembled and revealed more charred residue and stains inside the teflon body.In addition, a broken tip of the electrode was found stuck inside the hf connector base.The most probable cause of the reported event is attributed to user error.Incorrect assembly of the electrode into the device can cause sparks to discharge and damage to the teflon body.If additional information becomes available this report will be supplemented accordingly.

Event Description

Olympus was informed that during a therapeutic procedure the working elements caught on fire and unable to insert the electrode.It is unknown if the intended procedure was completed.No patient injury was reported.

Manufacturer Narrative

The oem performed the manufacturing and quality review for the device and revealed no deviations regarding the function and safety of the device.The dhr review revealed no abnormalities/non-conformities for this device.

• Brand Name: WORKING ELEMENT, PASSIVE
• Type of Device: WORKING ELEMENT, PASSIVE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6488907
• MDR Text Key: 72660919
• Report Number: 2951238-2017-00234
• Device Sequence Number: 1
• Product Code: GCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2017

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: No Information
• Device Model Number: WA22067A
• Device Catalogue Number: WA22067A
• Device Lot Number: 157W - 0060
• Other Device ID Number: 04042761051620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2017
• Initial Date FDA Received: 04/12/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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