MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-H190

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Event Description

The customer reported to olympus the evis exera iii gastrointestinal videoscope, had obstruction in the biopsy channel (the forceps does not fit) and the control wheels have looseness.The issue occurred during an unknown event and unkown procedure.There are no reports of patient or user harm associated with this event.

Manufacturer Narrative

To date, the customer have not returned the device for evaluation.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This is a supplemental report to correct the initial mdr.Upon further review by the legal manufacture, it was determined that the reportable malfunction included in the initial medwatch report with mfr# 9610595202401220 was erroneous (1384 - mechanical problem).Additional review revealed that the reported device problem (obstruction in the biopsy channel (the forceps does not fit) and the control wheels have looseness) is not a malfunction reportable product failure.Per the legal manufacturer, this issue is not likely to cause or contribute to death or serious injury if the malfunction were to recur.

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18543823
• MDR Text Key: 333320304
• Report Number: 9610595-2024-01220
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305290
• UDI-Public: 04953170305290
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1