MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SNARE WIRE

Model Number MAJ-218

Device Problems Device Contamination with Chemical or Other Material (2944); Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, the allegation was confirmed.Foreign matter was found adhered to the product after sterilization.Olympus provided reprocessing procedure to the customer.It seems the facility is cleaning and sterilizing (reprocessing) according to the instruction manual.The gauze provided in the packaging is the gauze normally used for wiping as it is less fuzzy.There was a change in the cleaning staff at the facility and the new personnel brought attention to the current matter.Additional information has been requested regarding this event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information becomes available.

Event Description

An olympus employee reported on behalf of the customer, after being ac (autoclave) sterilized the snare wire experienced frequent cases of fibrous matter adhering to the tip of the wire.The event occurred during reprocessing of subject device.There is no report of patient harm associated with this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the foreign matter was caught in the gaps between the twisted wires and had the properties of translucent resin (fluorine resin).Therefore, the root cause of the reported event is unable to be determined.The event can be detected by following the instructions for use (ifu) which state: ¿ after use, clean, sterilize and store according to the instructions in chapters ¿6 care¿ on page 30 and ¿7 storage on page 40.Improper cleaning, sterilization, and storage may lead to infection, damage to the device, and failure to ensure proper functionality.Olympus will continue to monitor field performance for this device.

• Brand Name: SNARE WIRE
• Type of Device: WIRE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15888204
• MDR Text Key: 307769368
• Report Number: 9614641-2022-00678
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04953170035739
• UDI-Public: 04953170035739
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K955650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: MAJ-219 L/N: K2106.SD HANDLE L/N: 8ZK.