MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR, 0.2 WIRE; HF-RESECTION ELECTRODES

Catalog Number WA22306D

Device Problems Air Leak (1008); Inappropriate/Inadequate Shock/Stimulation (1574); Noise, Audible (3273)

Patient Problem Internal Organ Perforation (1987)

Event Date 07/15/2014

Event Type  Injury  

Event Description

Cross-reference to / duplicate of mfr report # 9610773-2014-00032.Olympus was informed that during a therapeutic transurethral resection of the bladder tumor (turbt) procedure, error code "e006 - non-conductive fluid" was displayed on the esg-400 electrosurgical generator after the operating surgeon activated the high-frequency output (output mode/output power level/120 w/20 while the distal end/tip of the hf resection electrode was located in an air bubble inside the pt's bladder.Once the procedure was continued, a popping sound occurred inside the pt's bladder and the operating surgeon felt a mechanical shock at his hand which was currently placed on the pt's lower abdomen.After the surgical team realized that the pt has sustained a bladder perforation, the procedure was converted to conventional/open surgery.The following attempt to repair the perforation was not successful as the air leaking from the bladder could not be stopped.Subsequently, a total cystectomy was performed and the pt was finally hospitalized.

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 product are returned for eval/investigation 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.See scanned page.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR, 0.2 WIRE
• Type of Device: HF-RESECTION ELECTRODES
• 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: 4060122
• MDR Text Key: 20107298
• Report Number: 9610773-2014-00031
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: WA22306D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2014
• 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
• Treatment: CAT #WB91051W, SN #(B)(4); OLYMPUS ESG-400 ELECTROSURGICAL GENERATOR:
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR