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U.S. Department of Health and Human Services

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

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AIZU OLYMPUS CO., LTD. EVIS EXERA III DUODENOVIDEOSCOPE Back to Search Results
Model Number TJF-Q190V
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/02/2021
Event Type  Injury  
Manufacturer Narrative
The device referenced in this report was not returned to omsc for evaluation.The root cause of the user¿s report cannot be conclusively determined but the most likely causes for the reported phenomenon (distal end cover falling off) are as follows: 1) distal cover was attached inappropriately.2) scope distal end had some abnormality such as adhesion of foreign material, breakage.3) scope distal end received greater stress during procedure such as frictional load by twisting / pushing / pulling scope in body than the pulling or twisting stress user applied to distal cover during inspection prior to use.The device history record was unable to be reviewed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.This report was submitted by the importer under the importer's report number: 2429304 - 2023 - 00014.
 
Event Description
It was reported by an olympus representative on behalf of a user facility that during a therapeutic endoscopic retrograde cholangiopancreatography (ercp) procedure, the single use distal cover became detached from the evis exera iii duodenoscope.The cover fell off but was retrieved successfully by a roth net.The retrieval caused a surgical delay while the patient was under general anesthesia, but the time frame was not specified.The cap was on correctly, but it was stated that it may have gotten hooked on the trocar and over time slipped off.No irregularities were seen before attaching it to the scope.The physician did make sure the cover was securely on the scope by twisting or pulling to make sure it would not come off.No anti-fog agent was applied to the lens.The procedure was completed with the same devices.No patient harm was reported.This is related to patient identifier number (b)(6) which was reported under mfr.Report number 8010047-2021-09368.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the final investigation, it is likely that the distal cover endured greater stress during the procedure than the stress applied during the inspection of the device prior to use (pulling or twisting stress).This is evident because the trocar contacted the distal end of the subject scope.However, the root cause could not be identified.This supplemental report includes a correction to d4.Information has been added to d4 that was inadvertently not included on the initial medwatch.Olympus will continue to monitor field performance for this device.
 
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Brand Name
EVIS EXERA III DUODENOVIDEOSCOPE
Type of Device
DUODENOVIDEOSCOPE
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 Key16320150
MDR Text Key309016490
Report Number9610595-2023-01959
Device Sequence Number1
Product Code FDT
UDI-Device Identifier04953170405563
UDI-Public04953170405563
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K220587
Number of Events Reported1
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 02/22/2023
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? Yes
Device Operator Health Professional
Device Model NumberTJF-Q190V
Device Catalogue NumberN5992941
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/02/2021
Initial Date FDA Received02/08/2023
Supplement Dates Manufacturer Received02/11/2023
Supplement Dates FDA Received02/22/2023
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 Initial
Patient Sequence Number1
Treatment
MAJ-2315: LOT UNKNOWN
Patient Outcome(s) Required Intervention;
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