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

Model Number WA22351C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

There was no device returned to olympus for evaluation/investigation since there was no malfunction and the hf resection electrodes were discarded by the user facility after the procedures.Therefore, the exact cause of the reported complications and the patients' outcomes could not be determined and is being judged as unknown.Furthermore, a manufacturing and quality control review could not be performed since basic data of article identification (lot number) are missing.The case will be closed from olympus side with no further actions.However, the reported phenomenon will be recorded for trending and surveillance purposes.

Event Description

Olympus was informed that after different transurethral resection of the bladder tumor in saline (turis-bt) procedures at unknown dates, several patients developed urethral strictures.In addition, it was reported that some of these complications required surgical intervention to prevent permanent impairment.No further information was provided and there was no report of any equipment malfunction.

• Brand Name: HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12° AND 30°, STERILE, SINGLE USE
• 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 ; 4940669662
• MDR Report Key: 7402195
• MDR Text Key: 104534673
• Report Number: 9610773-2018-00035
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK100275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• 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
• Other Device ID Number: 14042761051719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2018
• 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