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

Model Number GIF-H190

Device Problem Partial Blockage (1065)

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

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not yet been evaluated by olympus, although it is anticipated.The investigation is ongoing.This report will be updated upon completion of the investigation or receipt of additional relevant information.

Event Description

The customer reports an evis exera iii gastrointestinal videoscope was recently returned from repair (around two weeks prior).During first use, the customer noticed difficulty in advancing accessories during polypectomy.A manual brushing was performed, and an obstruction was found approximately 1 cm from suction channel.There was difficulty in advancing brush from distal end noted.Negative manual seal test.Sequence of events as follows: during a colonoscopy procedure with polypectomy, after a cold removal of a polyp removed with a loop, it was necessary to place a metal clip.The device (clip) did not come out of the instrument (scope).The instrument was tested before use where no problems were found.The procedure was completed with a delay of about 10 minutes, using the same instrument and replacing the device with a similar one but with little result.The device did not come out of the instrument, the doctor opted not to apply the clips with the potential risk of bleeding of the polyp.There were no injuries to the operators.The application of metal clips after cold loop polypectomy is not performed routinely.It depends on various factors, including the patient's current therapy, site of the polypectomy, and size.The placement of clips was decided as a primary prophylactic treatment for this patient.No post-operative bleeding occurred.There were no additional consequences to the patient reported.

Manufacturer Narrative

This report is being updated to provide investigation findings.Physical evaluation of the returned device: the user's report of blocked channel was not confirmed.- due to a crack on grip, water tightness was lost - there was a gap between control section and s-cover - switch box had a scratch - c-cover was deformed - objective lens had a scratch - universal cord had a scratch - the scope was tested with 3 different brushes and no obstruction was found.The following repair was performed in the past year.On mar.9, 2022: failure in angulation range, squeezed insertion tube, cracks on ob-lens, and so on were found.Repair was performed.On may 26, 2022: failure in angulation range, squeezed insertion tube, cracks on ob-lens, and so on were found.Repair was performed.We confirmed via device history record (dhr) review that the device satisfied the design and safety specifications when it was shipped.Conclusion: we were not able to specify the root cause.Consideration: the cause of the event could not be specified from the following investigation results.There was no feeling of blockage in channel of the subject device during olympus inspection.¿the scope was tested with 3 different brushes and no obstruction was found.¿ the user attempted to insert 2 boston scientific resolution 360 clips, however both of them could not be inserted.Used 2 resolution 360 boston scientific metal clips (none came out of the instrument).

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14955267
• MDR Text Key: 295477525
• Report Number: 8010047-2022-11565
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305290
• UDI-Public: 04953170305290
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2022

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-H190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/08/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 09/21/2022
• Supplement Dates FDA Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: No
• 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: 2 RESOLUTION BS METAL CLIPS
• Patient Outcome(s): Other