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

Model Number MAJ-218

Device Problem Device Handling Problem (3265)

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

Event Date 10/04/2022

Event Type  malfunction  

Event Description

As reported for this device by the customer, the device was new and used for set up without sterilization as required for a new device prior to being used.There is no patient involvement.The intended procedure was completed with another similar device, since the device had an issue of not being able to be inserted in the sheath.

Manufacturer Narrative

The device has been returned but the device evaluation is not yet completed.As such, a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as any relevant new information becomes available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the device evaluation.Please see updates to h3, h4, h6, h8, and h10.H4: based on the 3 digit lot number that was provided, the manufacturing date of the device was in the month of september 2021 but a specific date could not be identified.The device was returned to olympus for inspection, and the customer's complaint was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it¿s likely the reported event was caused by an increase in the sliding resistance of the operation wire due to the narrowing of the hole through which the snare loop passes inside the water pipe.It's probable the internal diameter of the snare tube narrowed due to the physical load in the direction of compression applied to the connection between the coil and the cock of the insertion part, but it was not possible to identify the circumstances of this occurrence.Additionally, it¿s probable the customer did not correctly understand the cleaning/sterilization process, as sterilization before use was not preformed.A final root cause was unable to be identified.The following is included in the instructions for use: ¿this instruction manual contains essential information on using this instrument safely and effectively.Before use, thoroughly review this manual and the manuals of all equipment which will be used during the procedure and use the instruments as instructed.Keep this and all related instruction manuals in a safe, accessible location.This product is not sterilized prior to shipment.Before first use, clean and sterilize according to the instructions in chapter "6¿ on page 30.The medical literature reports incidents of patient cross contamination resulting from improper cleaning, or sterilization.It is strongly recommended that reprocessing personnel have a thorough understanding of and follow all national and local hospital guidelines and policies.All individuals responsible for reprocessing should thoroughly understand: your institution¿s reprocessing procedures.Occupational health and safety regulations.National and local hospital guidelines and policies.The instructions in this manual.The mechanical aspects of endoscopic equipment.Pertinent germicide labeling.Do not coil the insertion portion in a diameter of less than 15 cm.This could damage the insertion portion.When inserting the insertion portion into the endoscope, hold it close to the biopsy valve and keep it as straight as possible relative to the biopsy valve.Otherwise, the insertion portion could be damaged.Do not advance or extrude the instrument abruptly.This could result in perforation, bleeding or mucous membrane damage.It could also damage the endoscope or instrument.Do not forcefully squeeze, wipe or scrub the snare wire, snare tube, sd handle or a cord.This could cause damage to the snare wire, snare tube, sd handle or a cord or result in reduced performance.If tissue is snared with excessive force, the snare loop or the tube may become deformed.If this occurs, do not use the instrument; use a spare instead.Do not use excessive force when snaring tissue.This could result in bleeding or mucous membrane damage.Never use excessive force to open or close the snare loop.This could damage to the snare wire, snare tube or sd handle.¿ 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 Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15677140
• MDR Text Key: 307102658
• Report Number: 9614641-2022-00539
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-218
• Device Lot Number: 19K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1