MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12° AND 30°, STERILE, SINGLE USE, 12; HF-RESECTION ELECTRODES

Model Number WA22351C

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Perforation (2001)

Event Date 11/04/2015

Event Type  Injury  

Manufacturer Narrative

The suspect medical device was not returned to olympus for evaluation/investigation as it was reportedly discarded by the user facility after the procedure.Therefore the exact cause of the patient's outcome and the reported phenomenon could not be determined and is being judged as unknown.Furthermore, a manufacturing and quality control review could not be performed as basic data of article identification (lot number) are missing.The case will be closed from olympus side with no further actions but may be reopened if additional significant information becomes available at a later time.Then, this report will be updated.Furthermore, the event/incident will be recorded for trending and surveillance purposes.

Event Description

Olympus was informed that during a transurethral resection of the bladder tumor (turbt) procedure, the suspect medical device was not performing as expected.This prompted the operating surgeon to apply pressure to the bladder wall.When the performance of the hf resection electrode became normal again unexpectedly, the continued application of pressure caused a perforation of the bladder.The procedure was then converted to open surgery (laparotomy) where the perforation was sutured.No further information was provided, but the patient was in stable condition post procedure and has since been discharged from hospital.

• Brand Name: HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12° AND 30°, STERILE, SINGLE USE, 12
• Type of Device: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O.; telickova 457/29; prerov, 75124 ; EZ 75124
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg, 22045 ; GM 22045 ; 40 66966
• MDR Report Key: 5229125
• MDR Text Key: 31357576
• Report Number: 9610773-2015-00056
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K100275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WA22351C
• Device Catalogue Number: WA22351C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2015
• 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
• Treatment: OLYMPUS SURGMASTER ELECTROSURGICAL UNIT UES-40
• Patient Outcome(s): Required Intervention