MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD BALLOON

Model Number	MAJ-213
Medical Device Problem Codes	Contamination (1120); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Address- (b)(6).The subject device was received and evaluated at service center olympus hong kong.Device evaluation service repair technical report (ter) provided photos of the device return , showed one (1 ) maj-213 balloon has stain in the surface and the other balloon (maj-213) has a hole.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
As reported, 1pc of maj-213 has stain in the surface and 1pc of maj-213 has a hole with lot number #18r.The issue found at preparation for use for a diagnostic procedure.There was no patient harm, no user injury reported due to the event.
Additional Manufacturer Narrative
There will be no medwatch report with patient identifier (b)(6).Per the legal manufacturer, there is no potential for this issue (hole in the balloon) to cause or contribute to death or serious injury if the malfunction were to recur.
Additional Manufacturer Narrative
This report is being supplemented to correct b5 and h6 of the initial report.This medwatch is being submitted for the device with a stain on the surface.
Event or Problem Description
As reported, 1pc of maj-213 has a stain on the surface and 1pc of maj-213 has a hole with lot number #18r.The issue found at preparation for use for a diagnostic procedure.There was no patient harm, no user injury reported due to the event.This medwatch is being submitted for the device with a stain on the surface.Medwatch with patient identifier (b)(6) is being submitted for the device with a hole.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.The device history record was unable to be reviewed for this device; 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 definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: BALLOON
• Common Device Name: BALLOON
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15344976
• Report Number: 3002808148-2022-01651
• Device Sequence Number: 5134596
• Product Code: ITX
• UDI-Device Identifier: 04953170355714
• UDI-Public: 04953170355714
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K172618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/11/2022

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: MAJ-213
• Device Lot Number: 18R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2022
• Supplement Date Received by Manufacturer: 09/09/2022; 10/11/2022; 10/11/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 10/03/2022; 10/11/2022; 10/11/2022
• 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
• Patient Sex: Unknown