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 01/17/2022

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 a therapeutic resection of hysteromyoma procedure, when cutting in saline, the loop wire at the distal end of two hf electrodes broke off inside the patient consecutively with a sound of balloon explosion.However, no fragments remained inside the patient since they were reportedly retrieved.The intended procedure was completed and there was no report about an adverse event or patient injury.

Manufacturer Narrative

Device evaluation: the suspect medical device and the concomitant hf-generator were not returned to the manufacturer for investigation/evaluation but to olympus china sales and marketing (ocsm) (returned to ocsm on 2022-02-10 and 2022-01-21 respectively).The evaluation/investigation at ocsm found the hf-generator to be in standard condition and confirmed that the loop wires at the distal end of both affected hf-resection electrodes are broken off with traces of heat generation at the insulating sleeves.Since the loop wire at the distal end of an electrode wears out during use and may break, burn or melt, the reported event is attributed to wear and tear and thus to use error.Error message e006 that was reportedly issued by the hf-generator can have multiple causes and occurs if the resistance becomes too high at certain connections.Increased resistance may lead to faster wear of the electrode.The cause of reported popping sound cannot be conclusively be determined but may possibly be attributed to a minor oxyhydrogen explosion, which also could have contributed to the breakage of the electrodes.However, there is no causal relationship to the reported error message.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot numbers of both hf-electrodes without showing any abnormalities.The case will be closed on olympus side with no further actions.However, the reported phenomenon will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

Event Description

Olympus was informed that during a therapeutic resection of hysteromyoma procedure, when cutting in saline, the loop wire at the distal end of two hf electrodes broke off inside the patient consecutively with a sound of balloon explosion.However, no fragments remained inside the patient since they were reportedly retrieved.The generator at hand showed error e006.The intended procedure was completed and there was no report about an adverse event or patient injury.

• 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 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 ; 4940669662
• MDR Report Key: 13511981
• MDR Text Key: 294654561
• Report Number: 9610773-2022-00074
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761051665
• UDI-Public: 14042761051665
• 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,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2023
• Device Model Number: WA22302D
• Device Catalogue Number: WA22302D
• Device Lot Number: 1000037087
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2019
• 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 ESG-400 ELECTROSURG. GENERATOR (WB91051C); OLYMPUS TELESCOPE, 12°, 4 MM (A22001A)
• Patient Sex: Female