MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 30°, STERILE, SINGLE USE; HF-RESECTION ELECTRODES

Model Number WA22306D

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

Patient Problem Internal Organ Perforation (1987)

Event Type  Injury  

Manufacturer Narrative

The suspect medical device was not returned to olympus for evaluation/investigation since it was reportedly discarded by the user facility.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 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 during a therapeutic transurethral resection of the bladder tumor (turbt) procedure at an unknown date, the patient sustained a perforation of the bladder.Later the same day, the perforation was treated by open surgery (laparotomy).Furthermore, there were no reports of any device malfunctions and the turbt was completed with the same set of equipment.The patient reportedly recovered.

Manufacturer Narrative

A material or quality problem can be excluded since a manufacturing and quality control review was performed for the eligible lot numbers of the hf resection electrode without showing any abnormalities.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 30°, STERILE, SINGLE USE
• Type of Device: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer (Section G): OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O.; telickova 457/29; prerov, 75124
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg ; 4940669662
• MDR Report Key: 7166948
• MDR Text Key: 96447755
• Report Number: 9610773-2018-00001
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK100275
• 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,Followup
• Report Date: 01/18/2018

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: WA22306D
• Device Catalogue Number: WA22306D
• Other Device ID Number: 14042761051689
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 01/05/2018
• Supplement Dates Manufacturer Received: 01/17/2018
• Supplement Dates FDA Received: 01/18/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention