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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 Contamination (1120)
Patient Problem Unspecified Tissue Injury (4559)
Event Type  malfunction  
Event Description
Olympus was informed of two events in which patients sustained a tissue damage when a duodenovideoscope was being withdrawn.The procedure performed was an endoscopic retrograde cholangiopancreatography (ercp) to treat common bile duct (cbd) stones.Hold kc 02.15.The patients required no medical or surgical intervention as a result of this reported event.The first patient is an in-patient in the hospital due to her diagnosis.This patient was monitored for several days post-procedure.The patient was reportedly doing fine.No additional information available regarding the second patient.During bedside cleaning, technician found tissue in the distal end cap, and the physician was made aware of this findings immediately.The distal end cap was discarded after the procedures and cannot be returned for evaluation.Customer stated that they are sure that the cap was in proper position before and after the procedure.The physician was sure that he did not suction on the way out.Event one: patient identifier (b)(6), which was reported under mfr.Report number 8010047-2021-004415.Patient identifier (b)(6).Event two: patient identifier (b)(6), which was reported under mfr.Report number 8010047-2021-004416.Patient identifier (b)(6), which is the subject of this report.
 
Manufacturer Narrative
The device referenced in this report was not returned to olympus for evaluation.The device history record was unable to be reviewed, as the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The definitive cause of the reported events could not be established.Based on investigation findings, the following are presumed to be the likely causes: 1) user operates suction while distal end opening space was near the surface of mucosa, which causes the mucosa sucked into distal cover.When user tried to remove scope in this situation, the mucosa is damaged by the edge of the distal cover.2) distal cover cracks at tear-offline due to inappropriate attachment of distal cover to scope.When pressing distal end to surface of mucosa in this situation, the mucosa gets caught in the cracked cover and damaged, even though suction is not operated.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.
 
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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 190-0 182
JA   190-0182
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key16337161
MDR Text Key310125424
Report Number3003637092-2023-00036
Device Sequence Number1
Product Code FDT
UDI-Device Identifier04953170403019
UDI-Public04953170403019
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
Remedial Action Recall
Type of Report Initial
Report Date 02/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMAJ-2315
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/11/2021
Initial Date FDA Received02/09/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberZ-1292-2021
Patient Sequence Number1
Treatment
TJF-Q190V, SERIAL NUMBER UNKNOWN
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