MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE 3-LUMEN EXTRACTION BALLOON V

Model Number	B-V233P-A
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.The cause of the issue is unknown at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation, or if any additional information is provided by the user facility.
Event or Problem Description
An olympus representative reported on behalf of the customer that during the initial clinical use of the device the balloon on single use 3-lumen extraction balloon v would not deflate.The balloon was pulled through the endoscope and then popped.The reported malfunction was found during an unspecified therapeutic procedure.There were no reports of patient or user harm associated with this event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information, based on the legal manufacturer's final investigation and device evaluation.The device was evaluated.And the reported issue (balloon failure to deflate) could not be confirmed, (the balloon could not be deflated for testing).However, the complete device inspection results are as follows: minor kinks were observed, on the insertion tube portion of the sheath.The fluoro tip was examined under the microscope.And the balloon was confirmed, to have popped.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, the root cause of the reported event (balloon failure to deflate) could not be determined.However, the issue was likely, caused by the following mechanism: 1) a force beyond the strength resistance was applied to the balloon, when retrieving stones such as calculi, pancreatic and common bile duct stones.2) the fixed area at the rear end of the balloon broke.And it was displaced to the distal end.3) a hole for inflating and deflating the balloon was exposed.4) the balloon could not deflate.The event can be detected/prevented, by following the instructions for use (ifu), which state: ¿before use, prepare and inspect the instrument as instructed below.Should any irregularity be observed, do not use the instrument.Use a spare instead.Damage or irregularity may compromise patient or user safety, pose an infection-control risk, cause tissue irritation, perforation, bleeding or mucous membrane damage.And may result in more severe equipment damage¿.¿inflate the balloon only with air.Inflation with anything other than air may hinder expansion and contraction of the balloon¿.¿if it is difficult to pull the plunger of the premeasured syringe when deflating the balloon, detach the premeasured syringe from the air-feeding port¿.¿if resistance is too strong and withdrawal is difficult, adjust the angle of the endoscope until the instrument can be withdrawn smoothly.Forcible withdrawal of the instrument could damage the instrument and/or endoscope¿.¿when using an endoscope equipped with a forceps elevator, do not withdraw the instrument from the endoscope, if the forceps elevator is up.This could damage the instrument¿.This supplemental report includes a correction to d4 (lot number), e2, e3, and h8 from the initial medwatch.Also, an update has been made to d9 and h3 from the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE 3-LUMEN EXTRACTION BALLOON V
• Common Device Name: SINGLE USE 3-LUMEN EXTRACTION BALLOON
• 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: 17505913
• Report Number: 9614641-2023-01144
• Device Sequence Number: 6101857
• Product Code: FGE
• UDI-Device Identifier: 04953170275692
• UDI-Public: 04953170275692
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K091495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: B-V233P-A
• Device Lot Number: 2ZV 02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCOPE(UNKNOWN MODEL)
• Patient Sex: Unknown