MAUDE Adverse Event Report: OLYMPUS WINTER AND IBE GMBH OLYMPUS ELECTRODE LOOP

Model Number WA22306D

Device Problems Break (1069); Charred (1086)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This supplemental report is being submitted as the device was returned to olympus for evaluation.A visual inspection of the device found that the loop was broken and melted.There are also char marks on the cutting loop due to thermal damage.It is most likely that the device may have come into contact with a metal material during the hf output, or the end user applied too much physical pressure on the loop during the procedure which led to the premature melting of the device.The instruction manual warns users: "when attaching the electrode, make sure not to push it too forcefully into the working element.Otherwise the electrode may be damaged.".

Event Description

Olympus was informed that during an unspecified procedure, the device loop broke.It is unknown if any device fragment fell into the patient and was retrieved.However, there was no patient injury reported.No further information was provided.Olympus followed up with the user facility in writing and via telephone to obtain additional information regarding the reported event, but with no results.

Manufacturer Narrative

This supplemental report is being submitted to correct to wa22306d for the model and catalog#.If additional information becomes available at a later time or if the device is returned, this report will be supplemented accordingly.

• Brand Name: OLYMPUS ELECTRODE LOOP
• Type of Device: OLYMPUS ELECTRODE LOOP
• Manufacturer (Section D): OLYMPUS WINTER AND IBE GMBH; kuehnstrasse 61, 22045; hamburg ; GM
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave; san jose, CA 95131 ; 4089355002
• MDR Report Key: 5125363
• MDR Text Key: 27420269
• Report Number: 2951238-2015-00473
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102781
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Followup
• Report Date: 10/22/2015

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: WA22306D
• Device Catalogue Number: WA22306D
• Device Lot Number: 13238P02L001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1