MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°, STERILE, SINGLE USE; HF-RESECTION ELECTRODES

Catalog Number WA22302D

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

Patient Problem Ulcer (2274)

Event Date 01/01/2008

Event Type  Injury  

Event Description

Olympus was informed that approx.One hour after a therapeutic transurethral resection of the bladder tumor in saline (turis-bt) procedure in 2008, the patient reportedly developed an urethral stricture and an mri showed that the blood flow within the patient's prostate was blocked.Furthermore, it was reported that the patient suffered from an ulcer on the skin between anus and scrotum.No further information was provided but there was no malfunction of the olympus medical devices.The intended procedure was reportedly completed by using the same set of equipment.

Manufacturer Narrative

The suspect medical device was not returned to olympus for evaluation/investigation.Therefore the exact cause of the patient's outcome 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.However, the event/incident will be recorded for trending and surveillance purposes and if additional significant information becomes available, this report will be updated.Olympus submits this incident as a medical device report (mdr) in abundance of caution.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°, STERILE, SINGLE USE
• Type of Device: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, 2204 5; GM 22045
• Manufacturer (Section G): OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O.; telickova 457/29; prerov, 7512 4; EZ 75124
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg, 22045 ; GM 22045 ; 4066966
• MDR Report Key: 4814171
• MDR Text Key: 5893371
• Report Number: 9610773-2015-00020
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: WA22302D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2015
• Initial Date FDA Received: 06/03/2015
• 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 OES PRO RESECTOSCOPE; OLYMPUS UES-40S ELECTROSURGICAL GENERATOR
• Patient Outcome(s): Other