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

Model Number WA22301D

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

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

Event Date 01/19/2023

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.However, the reported electrode breakage is a known error phenomenon and can very likely be attributed to component failure caused by wear and tear.The electrode's loop wire wears out during use and may burn or melt if broken.The affected device can then lose broken parts.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 transcervical resection (tcr) procedure, the loop wire at the distal end of the hf resection electrode broke off and fell into the patient.However, no fragment remained inside the patient since a ct scan was performed where no foreign objects were found inside the patient.The intended procedure was successfully completed with a similar device and there was no report about patient injury.

Manufacturer Narrative

This report is being supplemented to provide corrections to the initial with information inadvertently left out (a1, d8, e1 name, g2, and h6 type of investigation) and to provide correction to the initial (h3).The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, SMALL, 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
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 16361336
• MDR Text Key: 309371199
• Report Number: 9610773-2023-00486
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761051658
• UDI-Public: 14042761051658
• 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: Other,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22301D
• Device Catalogue Number: WA22301D
• Device Lot Number: UNKOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2023
• 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 ULTRASONIC GENERATOR USG-400
• Patient Sex: Female