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

Model Number GIF-HQ190

Device Problems Crack (1135); Mechanical Problem (1384); Peeled/Delaminated (1454); Material Twisted/Bent (2981)

Patient Problem Perforation (2001)

Event Date 07/03/2021

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has been returned to olympus for physical evaluation.Preliminary findings are reported.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.Physical evaluation of the complaint device reveals: the label on the scope connector is peeling.The scope passed the dunk test.There is a halo on the image.Boroscopy was performed and showed tear marks inside the channel.The angulation is low with play in the angulation knob.The cover plastic has scratches and dents.The lens glue is cracked and peeling.The lens is cracked.The insertion tube has minor scratches and there is a minor buckle.The scope connector has minor scratches and there is a dent on the gold pin (not affecting functioning).This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This event has been reported by the importer on mdr# 2951238-2021-00372.

Event Description

The customer reports during a esophagogastroduodenoscopy (egd) using an evis exera iii gastrointestinal videoscope, the patient experienced a perforation.Additional details have been requested regarding the patient and event.At this time, no further information has been provided.

Manufacturer Narrative

This report is being updated to report additional information provided by the customer (provider).

Event Description

Additional information provided by the customer (provider): the procedure being performed was an upper endoscopy for the indication of active gastrointestinal (gi) bleeding, and acute post-hemorrhagic anemia.The injury experienced by the patient is described as: a >2cm cratered ulcer in the duodenum with a bleeding visible vessel found during endoscopy (the reason for the procedure).The vessel was treated with epinephrine injection, bipolar cautery, and clip placement.Post-intervention there was no evident injury.However, overnight, patient clinically worsened, and computerized tomography (ct) showed free air consistent with perforation.The actual size of perforation was not confirmed as repeat endoscopy not performed.The patient was treated with total parenteral nutrition (tpn).Anatomical challenges that contributed to the perforation include: the large cratered ulcer with exposed vessel.The patient's current condition is described as much improved, gastrografin study and ct showing no extravasation.In ward bed, tolerating ice chips.Did not pass bedside swallow so maintaining tpn for now.The gif-hq190 did not malfunction in anyway.

Manufacturer Narrative

This report is being updated to report additional investigation findings.New information is reported in h6 and h10.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.Conclusion: the definitive cause of the reported event was not determined.Based on the available information the following are the possible causes: based on the review of a similar reported event, it could have been an accidental occurrence during the procedure, not due to endoscope.Although there were non-conformities of the device when inspected (and subsequently repaired), it is not known if any of the identified issues caused or contributed to the reported event.According to the information provided from the user in event description, the patient had a history of multiple disorders.We presume from this information that the event occurred accidentally due to these factors, not due to the device.

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12211305
• MDR Text Key: 262926380
• Report Number: 8010047-2021-09227
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305276
• UDI-Public: 04953170305276
• Combination Product (y/n): N
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 07/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/08/2021
• Initial Date FDA Received: 07/22/2021
• Supplement Dates Manufacturer Received: 07/26/2021; 10/06/2021
• Supplement Dates FDA Received: 08/17/2021; 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INJ. NEEDLE, BIPOLAR CAUTERY, HEMOSTATIC CLIP
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 63