MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH ELECTRODE; RESECTION ELECTRODE LOOPS AND BANDS

Model Number WA22302D

Device Problem Material Twisted/Bent (2981)

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

Event Date 10/25/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned and evaluated, and the customer¿s allegation was confirmed.In addition to the electrode being damaged, there were no additional findings.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.E1 hf-resection electrode, loop, 24 fr., 0.2 wire, medium, 12°, sterile, single use, 12 pcs., for turis.

Event Description

The customer reported to olympus that the hf-resection electrode, loop, 24 fr., 0.2 wire, medium, 12°, sterile, single use, 12 pcs., for turis direction of the resecting ring was abnormal.The event occurred during preparation for use.The procedure was completed with a similar device.There was no patient harm associated with the event.The device was evaluated, and it was found that the electrode is damaged and may break when used.This mdr (medical device report) is being submitted to capture the reportable malfunction found during the device evaluation.

• Brand Name: ELECTRODE
• Type of Device: RESECTION ELECTRODE LOOPS AND BANDS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18133836
• MDR Text Key: 328487351
• Report Number: 9610773-2023-03290
• 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: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: WA22302D
• Device Lot Number: 1000089607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2022
• 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: A22001A.