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Model Number TJF-Q170V
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Event Description
The olympus representative reported on behalf of the customer, during the endoscopic retrograde cholangiopancreatography (ercp), the single use distal cover fell off the duodenovideoscope inside the patient and migrated distally.The user performed forward-viewing endoscopy to retrieve the cap but could not find it.They tried to locate it by fluoroscopy but the cap was not radiopaque and there are no radiopaque markers on it.The patient was admitted, and the next morning the patient passed the cap in their stool which was retrieved and not damaged.Afterwards the customer did an experiment and kept the cap in the abdomen of another patient who was undergoing a computerized tomography (ct) scan and abdominal x-ray, and the cap was not visible on either ct scan nor the x-ray.The customer noted that the cap is for single use but they can be removed intact very easily, and in their country due to financial constraints, these caps are reused multiple times and is one of the main reasons for the dislodgement of the caps during the procedure.The distal cover in this procedure was a reused one.The caps are difficult to locate when they fall off inside the patient as they are not visible on x-rays or ct scans.No patient harm was reported.The customer did not apply anti-fog agent to the scope lens.There were no chemicals used during the procedure that could adhere to the tip of the scope or distal cover.There was no damage on the distal cover when attached to the scope.The customer did not pull and twist the distal cover to make sure it did not come off.Related patient identifiers: (b)(6) single use distal cover (maj-2315/ sn: (b)(6)).(b)(6) duodenovideoscope (tjf-q170v / sn: (b)(6)).This medwatch is for (b)(6).
Manufacturer Narrative
The device was not returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
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 over 1 year since the subject device was manufactured.Based on the results of the investigation, the reported event (distal cover detachment) occurred due to insufficient attachment to the scope.However, the root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) in sections: operation manual: chapter 3 (section 3.5) - prevention and operation manual: chapter 4 (section 4.1) ¿ detection.This supplemental report includes a correction to e1 and g2 from the initial medwatch.Also, information has been added to h4.Olympus will continue to monitor field performance for this device.
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Brand Name
Type of Device
Manufacturer (Section D)
3-1-1 niiderakita
aizuwakamatsu-shi, fukushima 965-8 520
JA  965-8520
Manufacturer (Section G)
3-1-1 niiderakita
aizuwakamatsu-shi, fukushima
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
MDR Report Key18561772
MDR Text Key333436742
Report Number9610595-2024-01412
Device Sequence Number1
Product Code FDT
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/29/2024
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-Q170V
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/28/2023
Initial Date FDA Received01/23/2024
Supplement Dates Manufacturer Received03/25/2024
Supplement Dates FDA Received03/29/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/10/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient SexMale