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 Problems Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2022

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 user's experience and the reported phenomenon could not be conclusively determined and is being judged as unknown.However, the reported failure is a known phenomenon usually caused by wear and tear.The loop wire at the distal end of the hf electrode may wear out during use and may break, burn or melt.Thus, this incident can most likely be attributed to user error.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the hf resection electrode without showing any abnormalities.The case will be closed from olympus side with no further actions.However, the reported event/incident will be recorded for trending and surveillance purposes.

Event Description

Olympus was informed that during a therapeutic transurethral resection of the prostate (turp) procedure, the loop wire at the distal end of the hf resection electrode broke off and fell into the patient's urethral prostate tissue.Due to the lack of a sheath and grasping forceps, the surgeon used a new hf loop resection electrode to remove the broken fragment and flush with a lot of rinsing fluid.However, the loop wire disappeared from the field of vision.The other doctors searched outside the body, and the chief surgeon repeatedly searched for broken parts in the surgical cavity but could not locate the fragment.An x-ray examination was performed but no fragments could be located.Since no abnormalities were identified during x-ray, it was assumed that the fragment was flushed out of the patient¿s body.No patient injury was reported.

• 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, 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: 16085298
• MDR Text Key: 306501402
• Report Number: 9610773-2023-00049
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K100275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22302D
• Device Catalogue Number: WA22302D
• Device Lot Number: 1000078193
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2021
• 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