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

Model Number WA22302D

Device Problem Physical Property Issue (3008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/11/2016

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device has not yet been returned to the manufacturer for evaluation/investigation.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.

Event Description

Olympus was informed that during a therapeutic transurethral resection of the prostate (turp) procedure, it was noticed that some radioactive seeds have been recovered, damaged and cut when the prostate tissue was cut away.These radioactive seeds were permanently implanted into the patient's prostate one year before as part of a prostate brachytherapy for treatment of prostate cancer.The user stated that the damage of the radioactive seeds caused a radiation protection issue since there was flaking of small pieces of radioactive metal leading to contamination.However, there was no adverse event or injury of a person.

Manufacturer Narrative

Device available for evaluation? device evaluation: there was no device returned to olympus for evaluation/investigation since there was no malfunction of the hf resection electrode.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, the number of brachytherapy procedures for prostate cancer is increasing.If followed by a turp procedure, the manufacturer presently acknowledges that the resection loop or other electrodes used may be damaged when contacting the seeds.The manufacturer also identified the need for further recommendations.For that reason, several departments are presently participating in a project, which aims to develop such recommendations (safe treatment of patients who have had brachytherapy procedures).Since this issue is rather comprehensive, various tests will have to be conducted.Once this project is finished, the resulting recommendations will also be incorporated into the instructions for use.

• 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
• Manufacturer (Section G): OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O.; telickova 457/29; prerov
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg ; 4940669662
• MDR Report Key: 6568456
• MDR Text Key: 75537364
• Report Number: 9610773-2017-00071
• 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: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22302D
• Device Catalogue Number: WA22302D
• Other Device ID Number: 14042761051665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/18/2017
• Initial Date FDA Received: 05/16/2017
• Supplement Dates Manufacturer Received: 10/06/2017
• Supplement Dates FDA Received: 10/10/2017
• 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: HF-CABLE, 4 M, UES-40 HF-UNIT TO TURIS (WA00013A); INNER SHEATH, FOR 26 FR. OUTER SHEATH (A22040A); OUTER SHEATH, 26 FR., 2 STOPCOCKS (A22026A); TELESCOPE, 12°, 4 MM (A22001A); WORKING ELEMENT, ACTIVE, FOR RESECTION (WA22366A)