MAUDE Adverse Event Report: OLYMPUS WINTER AND IBE GMBH HF RESECTION ELECTRODE

Model Number WA22606D

Device Problem Break (1069)

Patient Problems Internal Organ Perforation (1987); No Consequences Or Impact To Patient (2199)

Event Date 07/09/2015

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The exact cause of the reported event could not be conclusively determined as this time.If additional information or if the device becomes available at a later time, a supplemental report will be submitted.The instruction manual warns users: " when checking the locking of the electrode, make sure not to pull too forcefully.Otherwise the electrode's stabilizing tube may be damaged.If any damage to the insulation at the electrode's distal end is recognized during use, replace the electrode with an undamaged electrode.Otherwise there is a risk of injury for the patient and/or user.".

Event Description

Olympus was informed that during an unspecified procedure, the loop broke off on the right side of the electrode after the physician took two swipes.It was stated that the electrode was used in conjunction with a pk superpulse generator.The intended procedure was completed with another similar device.There was no patient injury reported.Olympus followed up with the user facility via telephone and in writing to obtain additional information regarding the reported event, but with no results.

Manufacturer Narrative

It was reported that during a transurethral resection of the prostate (turp) procedure the patient's urethra was perforated upon withdrawal of the device.It was reported that the first loop broke and was replaced with another similar device.As the physician was removing the second device it was observed that it was broken as well and a wire was protruding.It is unknown which of the three devices used in the procedure caused or contributed to the injury of the patient's urethra.The intended turp procedure was aborted.A catheter was placed in the patient to allow the urethra time to heal.It is also unknown if there was any abnormal bleeding.The patient will be re-scheduled at a later date to complete the turp procedure.No further information was provided.If additional information becomes available at a later time, this report will be supplemented.This is first of the three reports.Cross reference with mfr report#: 2951238-2015-00351 and 2951238-2015-00352.

• Brand Name: HF RESECTION ELECTRODE
• Type of Device: HF RESECTION ELECTRODE
• 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: 4988374
• MDR Text Key: 22439381
• Report Number: 2951238-2015-00342
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K903323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Report Date: 07/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22606D
• Device Catalogue Number: WA22606D
• Device Lot Number: 985859
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention