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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT SINGLE USE DISTAL COVER

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OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT SINGLE USE DISTAL COVER Back to Search Results
Model Number MAJ-2315
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Vomiting (2144); Discomfort (2330)
Event Date 11/14/2022
Event Type  Injury  
Manufacturer Narrative
The maj-2315 was disposed of by the customer.The tjf-q290v is not being returned to olympus for evaluation.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.
 
Event Description
The customer reported the doctor attached the tip cover (maj-2315) to the tjf-q290v and carried out the examination, which was a diagnostic endoscopic retrograde cholangiopancreatography (ercp) procedure.When the endoscope was removed from the patient's body at the end of the examination, the tip cover (subject device) fell off.The doctor did not notice that the tip cover had fallen off and ended the examination as it was.In the ward, the patient complained of discomfort in the pharynx, proceeded to vomit, and the tip cover was collected from the vomit.The tip cover was discarded by the user.There was no change in the patient's planned hospitalization period, and there was no problem with the patient's prognosis, as a result of the event.This report is being submitted for the maj-2315 (single use distal cover), under the medwatch with patient identifier (b)(6).The tjf-q290v (evis lucera elite duodenovideoscope) is being reported under the medwatch with patient identifier (b)(6).
 
Manufacturer Narrative
This report is being updated to report additional information provided by the customer.New information is reproted in b5.
 
Event Description
Update: additional information provided by the customer: the customer confirmed there were no adverse effects to the patient as a result of this occurrence.The patient's current condition is described as "good prognosis".
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, although the root cause could not be determined, the likely causes for the distal cover falling off the scope (maj-2315) are as follows: 1.Chemicals such as anti-fog agents adhered to the cover and were damaged by chemical attack, making it easy for the cover to come off the scope.2.The cover was easily removed from the scope due to insufficient attachment to the scope.3.When the cover was attached to the scope, the cover was damaged by pushing it diagonally, making it easy for the cover to come off the scope.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿attaching the distal cover: please make sure that the distal cover is intact without any problem before installation, and it has no damage(crack) after installation.¿ ¿also, do not use anti-fog agents as it is known that anti-fog agents will damage the cover.¿ this supplemental report includes a correction to d8, g2 and h4 from initial medwatch.Olympus will continue to monitor field performance for this device.
 
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Brand Name
SINGLE USE DISTAL COVER
Type of Device
DISTAL COVER
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT
34-3 hirai, hinode-machi
nishitama-gun, tokyo 190-0 182
JA  190-0182
Manufacturer (Section G)
OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT
34-3 hirai, hinode-machi
nishitama-gun, tokyo
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key15977808
MDR Text Key305461747
Report Number3003637092-2022-00106
Device Sequence Number1
Product Code FDT
UDI-Device Identifier14953170403016
UDI-Public04953170403019
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K220587
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup,Followup
Report Date 01/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMAJ-2315
Device Lot NumberH2225
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/20/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/25/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
TJF-Q290V EVIS LUCERA ELITE DUODENOVIDEOSCOPE.
Patient Outcome(s) Other;
Patient Age90 YR
Patient SexMale
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