MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH WORKING ELEMENT, ACTIVE; MONOPOLAR WORKING ELEMENTS

Catalog Number WA22066A

Device Problems Melted (1385); Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2014

Event Type  malfunction  

Event Description

Olympus was informed that during an unspecified transurethral resection of the prostate (turp) procedure, the suspect medical device sparked and the loop wire of the hf resection electrode burned/melted down inside the pt when activating the high-frequency output of the electrosurgical generator/unit (output mode/output power level: cut/150 w; coag /60 w).The intended procedure was reportedly completed by using a similar device and there was no report about an adverse event or pt injury.

Manufacturer Narrative

The suspect medical device and concomitant medical products were not yet returned to the mfr for eval/investigation.Therefore the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unk.However, if the suspect medical device and concomitant medical products are returned for eval or add'l significant info becomes available, this report will be updated.Olympus submits this incident as a medical device report (mdr) in abundance of caution.

• Brand Name: WORKING ELEMENT, ACTIVE
• Type of Device: MONOPOLAR WORKING ELEMENTS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 2204 5; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 0669662955
• MDR Report Key: 3905075
• MDR Text Key: 15327796
• Report Number: 9610773-2014-00023
• Device Sequence Number: 1
• Product Code: FDC
• Combination Product (y/n): N
• Reporter Country Code: HU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: WA22066A
• Device Lot Number: 135W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED ELECTROSURGICAL GENERATOR/UNIT; UNSPECIFIED HF RESECTION ELECTRODE
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 80