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

Model Number GIF-HQ190

Device Problem Device Damaged by Another Device (2915)

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

Event Date 01/31/2024

Event Type  Injury  

Event Description

It was reported that during a stomach biopsy procedure, a non-olympus forceps was caught within the gastrointestinal videoscope.The forceps joint came undone and the physician was unable to close the instrument.It was decided to pull hard on the scope and the forceps finally broke apart and the forceps were pulled through the scope's working channel.This was believed to have caused damage to the scope but it was stated that the issue was the dysfunctional forceps, not the scope.The forceps pieces were retrieved from the patient with a net, which created a 40 minute procedural delay while the patient was under anesthesia.Diagnostic imaging was utilized during the procedure as well as post operatively to confirm no retained forceps pieces were present within the patient.The procedure was completed but the scope failed the leak test immediately after the procedure and was taken out of service.The condition of the patient was not impacted by the failure.

Manufacturer Narrative

This report was submitted by the importer under the importer's report number: 2429304-2024-00206.The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide a correction to the initial with information inadvertently left out (g2) and to provide an update to (h3 and h4).The device was evaluated by olympus.Although there were non-reportable (non-pae) defects noted, there were no reportable (pae) device defects observed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the suggested event occurred due to the joint at the tip of the forceps detached by stress from inserting the forceps or taking tissue, which led to the forceps stuck in the biopsy channel.However, it was determined that there was no relationship between the device and the event.Additionally, a specific root cause of the reported event could not be identified.The event can be prevented by following the instructions for use which state: -operation manual chapter 5 troubleshooting."if any irregularity is observed during the inspection described in chapter 3, ¿preparation and inspection¿, do not use the endoscope and solve the problem as described in section 5.2, ¿troubleshooting guide¿." "if the problem still cannot be resolved, send the endoscope to olympus for repair as described in section 5.4, ¿returning the endoscope for repair¿." "also, should any irregularity be observed while using the endoscope, stop using it immediately and withdraw the endoscope from the patient as described in section 5.3, ¿withdrawal of the endoscope with an irregularity¿." olympus will continue to monitor field performance for this device.

• 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: 18955729
• MDR Text Key: 338308856
• Report Number: 9610595-2024-06082
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305276
• UDI-Public: 04953170305276
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-HQ190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2019
• 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
• Treatment: UNKNOWN BOSTON SCIENTIFIC FORCEPS
• Patient Outcome(s): Other