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

Model Number	GIF-XP150N
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspection and testing found foreign objects in the nozzle due to insufficient cleaning.The report from the customer was confirmed.The connecting tube was wrinkled, the play of the up/down knob was out of standard due to a worn angle wire, and the light guide bundle was broken causing illumination to be uneven.In addition, there was a cut on the bending section cover which resulted in a loss of water-tightness, the objective lens was chipped, the light guide lens was dirty, the adhesive on the bending section cover was detached, the bending section cover was worn, the connecting tube was scratched, there were cuts on the switches, the universal cord was scratched and sticky, the bending angle in the up direction did not meet standard value due to a worn angle wire, and water removal ability did not meet standard value due to clogging of the nozzle.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.
Event or Problem Description
The customer reported that there were wrinkles in the connecting tube of the scope, play in the angulation, and light output was low.The subject device was sent to an olympus service center for evaluation.During inspection and testing, foreign objects were found in the nozzle.This report is being submitted for the malfunction found during evaluation (foreign material).There was no harm or user injury reported due to the event.
Additional Manufacturer Narrative
Correction to g3 of the initial medwatch.The aware date should be (b)(6) 2022.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 11 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 have been due to inappropriate reprocessing after the previous procedure.The user can detect the suggested event properly by handling the device in accordance with the following instructions for use (ifu): "operation manual preparation and inspection: inspection of the endoscope inspect the air/water nozzle at the distal end of the endoscope¿s insertion section for abnormal swelling, bulges, dents, or other irregularities.Operation manual inspection of the endoscopic system, inspection of the air-feeding function, inspection of the objective lens cleaning function." the user can decrease and prevent occurrence of the suggested event by handling the device in accordance with the following ifu: "reprocessing manual_ cleaning, disinfection and sterilization procedures.Precleaning warning: if the endoscope is not immediately cleaned after each procedure, residual organic debris will begin to solidify and it may be difficult to effectively reprocess the endoscope.Flush water and air into the air/water channel.Caution: to prevent clogging of the air/water nozzle, always use the aw (air/water) channel cleaning adapter to clean the air/water channel after each use.Cleaning, disinfection and sterilization procedures manual cleaning, flushing detergent solution into the air/water channels, removing detergent solution from all channels, presoak for excessive bleeding and/or delayed reprocessing after each procedure.Caution: follow the steps below only in cases of excessive bleeding and/or delayed reprocessing; unnecessary immersions should be avoided.Consecutive reprocessing sessions using extended immersion may damage the endoscope." olympus will continue to monitor field performance for this device.

• Brand Name: 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: 14119494
• Report Number: 8010047-2022-06441
• Device Sequence Number: 2428237
• Product Code: FDS
• UDI-Device Identifier: 04953170229442
• UDI-Public: 04953170229442
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K051645
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

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-XP150N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2011
• 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