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

Model Number MAJ-2315

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Damage (2104)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during the endoscopic retrograde cholangiopancreatography (ercp) clinical demonstration using with the tjf-q290v which the subject device was attached, the patient had severely stenosis and the physician could not continue the procedure.Therefore the physician replaced the tjf-q290v to the jf-260v and completed the procedure.After the procedure, during the reprocessing the tjf-q290v, the subject device was detached from the tjf-q290v, the unspecified tissue (a piece of meat) came out from the subject device.The facility stated that before the procedure the facility had brushed the tjf-q290v and reprocessed the tjf-q290v with the oer-4.The user facility did not provide other detailed information.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was not returned to any of olympus locations because the user discarded the subject device.Therefore the lot number was unknown, the manufacturing history record could not be reviewed.However, omsc checked all manufacturing history record from starting the manufacturing of maj-2315, there was no abnormality relating the reported phenomenon.Omsc reviewed the manufacture history (dhr) of the subject device and confirmed no irregularity.Since the root cause analysis has been completed in capa.According to capa, the mechanism of occurrence of this event has been found to be as follows.[pattern 1]: procedure is started without noticing cracks in the tip cover during pre-use inspection.By performing the suction operation with the tip in close contact with the mucous membrane, the mucous membrane enters between the tip cover and the elevator.The endoscope was removed with the mucous membrane inserted between the tip cover and the elevator (the tip was adsorbed on the mucous membrane).The mucous membrane that has entered at the cracked part of the tip cover is excised, and a piece of mucous membrane remains in the tip cover.[pattern 2]: procedure is started without noticing cracks in the tip cover during pre-use inspection.Although no suction operation is performed, the mucous membrane enters between the tip cover and the elevator due to the strong contact between the tip and the mucous membrane.The endoscope is removed with the mucous membrane inserted between the tip cover and the elevator (the tip is in strong contact with the mucous membrane).The mucous membrane that has entered at the cracked part of the tip cover is excised, and a piece of mucous membrane remains in the tip cover.[pattern 3] by performing the suction operation with the tip in close contact with the mucous membrane, the mucous membrane enters between the tip cover and the elevator.The endoscope was removed with the mucous membrane inserted between the tip cover and the elevator (the tip was adsorbed on the mucous membrane).The mucous membrane that has entered at the edge of the tip cover (around the u-shaped slit) is excised, and a piece of mucosa remains in the tip cover.In addition, the root cause has been identified as follows from the mechanism of occurrence.[structure]: root cause 1: compared to conventional products, there is a space for mucous membrane to enter between the elevator and the tip cover.Root cause 2: compared to conventional products, the tip cover has an edge (around the u-shaped slit), and the edge is in a position where it can easily come into contact with the mucous membrane.[operation of the surgeon]: root cause 3: start the inspection without confirming that the tip cover is properly attached during the pre-use inspection (start the inspection with the tip cover cracked).Root cause 4: removing the endoscope with the tip adsorbed on the mucous membrane by suction operation.Patterns 1 to 3 shown in the mechanism of occurrence occur when a combination of several root causes is aligned.Pattern 1: when the combination of root causes 1 to 4 is aligned.Pattern 2: when the combination of root causes 1 to 3 is aligned.Pattern 3: when the combination of root causes 1, 2 and 4 is aligned.Regarding the relationship of the device to the reported incident or adverse event, although the use of the device caused tissue damage, it was judged that no additional treatment was necessary.The mechanism of occurrence of health damage is as described in the above-mentioned "cause analysis" items.In addition, as described in the above "cause analysis" items, it is considered that there is no suspicion of usability problems.As a result of risk analysis of this event, it was found that the mdr report type is "malfunction".

• Brand Name: SINGLE USE DISTAL COVER
• Type of Device: DISTAL COVER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11011384
• MDR Text Key: 221514987
• Report Number: 8010047-2020-10388
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170403019
• UDI-Public: 04953170403019
• Combination Product (y/n): N
• PMA/PMN Number: K193182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/05/2021

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 Number: MAJ-2315
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 06/10/2021
• Supplement Dates FDA Received: 07/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other