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

Model Number WA22566S

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

Patient Problem Urinary Retention (2119)

Event Type  Injury  

Manufacturer Narrative

There was no device returned to the manufacturer for evaluation/investigation.Therefore, the exact cause of the user's experience and the complications 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 but may be reopened if a device is returned for evaluation/investigation or additional significant information becomes available at a later time.Then, this report will be updated.In addition, the event/incident will be recorded for trending and surveillance purposes.

Event Description

Olympus was informed that a larger than expected number of patients developed urethral stricture following transurethral resection in saline (turis) procedures, where the hf resection electrode had been used.No further information was provided and neither the cause of the complications or information as whether the patients required any treatment is known.However, there were no reports of any device malfunctions.

• Brand Name: HF-RESECTION ELECTRODE, OVAL BUTTON, 24 FR., 12°-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: 6405646
• MDR Text Key: 69993656
• Report Number: 9610773-2017-00040
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PK152092
• 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

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 Model Number: WA22566S
• Device Catalogue Number: WA22566S
• Other Device ID Number: 14042761083765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2017
• Initial Date FDA Received: 03/15/2017
• 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 ESG-400 ELECTROSURGICAL GENERATOR
• Patient Outcome(s): Required Intervention