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 Date 09/29/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, the evis exera iii gastrointestinal videoscope had difficulty passing dilation balloon through working channel 18-20.The issue was found during a therapeutic endoscopic sleeve gastroplasty (egd) with dilation of gastric sleeve procedure completed using a similar device.There were no reports of patient harm.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was not confirmed.The device evaluation found labels were found peeling; the image did not show any dots; forceps passage had minor scratches; distal end plastic cover had deep dents and scratches; objective lens edges chipped and peeling glue; light guide lens glue is peeling; bending section cover glue cracked on both sides; visible damage was present on switches; upward angulation was found low, not according to specification.The investigation is ongoing and follow-up with the user facility is currently being performed.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 supplemental report is to correct the initial mdr.The initial medwatch reported the during the therapeutic esophagogastroduodenoscopy (egd) with dilation of gastric sleeve, there was difficulty with forceps insertion and passing the dilatation balloon through the working channel on the evis exera iii gastrointestinal videoscope causing a prolongation in the procedure.Two disposable dilation balloons were wasted and after two balloons would not pass (but cleaning brush would pass), a different gif-h190 and a new balloon were used without issue.The procedure was not cancelled or postponed, and was completed with another similar device.The procedural delay is not considered life-threatening, nor did it lead to a permanent impairment in the patient.The initial report was reported out of caution as the iuc is unknown-pae.However, all the final fuc codes are non-pae.Additionally, the prolongation of the procedure has been determined to be not a serious injury.Per the legal manufacturer, there is no potential for this issue 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: 17941236
• MDR Text Key: 325752019
• Report Number: 9610595-2023-15240
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305290
• UDI-Public: 04953170305290
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2015
• 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