MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

Model Number	GIF-N180
Medical Device Problem Codes	Device Reprocessing Problem (1091); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to olympus that evis exera ii gastrointestinal videoscope has a leak.Upon inspection and testing of the customer returned device, the repair center found foreign material cannot be removed even if the correct reprocess is performed due to the buckling of the channel.This report is being submitted for the event found at estimation.There was no report of death, harm or patient injury.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation.A review the images provided confirmed the device channel is buckling.Further review of the device also noted the channel is clogged and there was a foreign material within the channel.Additionally, there were black spots on the image, and the bending section tube had defects.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Additional Manufacturer Narrative
Correction to g3 of the initial medwatch.The aware date should be 29-dec-2021.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 9 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon was presumed to be due to the following: ·because of inappropriate device handling, the biopsy channel was deformed.And the biopsy channel was clogged with an endo therapy accessory, because the user inserted the endo therapy accessory into the biopsy channel while the biopsy channel was deformed.·during the procedure performed before detection of the suggested event, a way of using an endo therapy accessory by the user was not appropriate, and then, the biopsy channel was clogged with the endo therapy accessory.Users can detect the suggested event properly by handling the device in accordance with the following instructions for use (ifu): "·inspection of the instrument channel - insert the endotherapy accessory through the biopsy valve.Confirm that the endotherapy accessory extends smoothly from the distal end.Also make sure that no foreign objects come out of the distal end.".Users can decrease/prevent the suggested event by handling the device in accordance with the following ifu: "·do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.·do not coil the insertion tube or universal cord with a diameter of less than 12 cm.Equipment damage can result.·if insertion or withdrawal of endotherapy accessories is difficult, straighten the bending section as much as possible without losing the endoscopic image.Inserting or withdrawing endotherapy accessories with excessive force may damage the instrument channel or endotherapy accessories and could cause some parts to fall off and/or cause patient injury.".Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
• Common Device Name: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13372676
• Report Number: 8010047-2022-02097
• Device Sequence Number: 11629428
• Product Code: FDS
• UDI-Device Identifier: 04953170339080
• UDI-Public: 04953170339080
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K100584
• 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
• Report Date (Section B): 04/28/2022

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: GIF-N180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2022
• 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: 01/06/2022
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown