MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP,; HF_RESECTION ELECTRODES

Model Number WA22302D

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

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

Event Date 05/22/2020

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device has not yet been returned to olympus 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 an unspecified therapeutic hysteroscopic procedure, the loop wire at the distal end of the hf resection electrode broke about 0.5mm from the distal end and the fragment most likely fell into the patient¿s body.Then, the user continued the procedure with another resectoscope and electrode, but the electrode broke again 0.2mm from the distal end.An x-ray was taken where no foreign objects were noted.The intended procedure was successfully completed without significant prolongation and there was no report about an adverse event or patient injury.

Manufacturer Narrative

The suspect medical device was not returned to olympus for evaluation/investigation.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, based on the customer's event description, the reported damage was most likely caused by thermal overload due to the unintended contact with an iud embedded in the tumor that was to be removed during the procedure.It is assumed that the short circuit that occurred as a result of the contacting caused the cutting wire of the electrode to melt at the contact point, since no loop fragments could be localized in the patient¿s body.Therefore, this event/incident was attributed to use 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 resection electrode without showing any abnormalities.The case will be closed on olympus side with no further actions and the reported event/incident will be recorded for trending and surveillance purposes.

• Brand Name: HF-RESECTION ELECTRODE, LOOP,
• Type of Device: HF_RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 10301159
• MDR Text Key: 199737376
• Report Number: 9610773-2020-00162
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761051665
• UDI-Public: 14042761051665
• Combination Product (y/n): N
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2024
• Device Model Number: WA22302D
• Device Catalogue Number: WA22302D
• Device Lot Number: 1000043937(GRXCX)
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS HF-GENERATOR ESG-400 (WB91051C).; OLYMPUS HF-GENERATOR ESG-400 (WB91051C)