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

Model Number MAJ-2315

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  malfunction  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation and the investigation is in process.The lead technician stated it is the doctor's standard practice to remove non-olympus stents through the scope channel.He also stated the doctor's patient population consists of more complex and difficult cases, sometimes with altered anatomy.At times, when the doctor is removing the stent through the scope, the bending section is retroflexed because of the patients' abnormal anatomy.The lead technician stated it is possible this may be a contributing factor of the cap issues recently experienced.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

Event Description

Two different events (b)(6) 2021 and (b)(6 2021 were reported where there was human tissue found in the evis exera iii duodenovideoscope forceps elevator after the procedures were completed, before sending the scope to reprocessing.The physician was performing a therapeutic endoscopic retrograde cholangiopancreatography for both events.In both events, the human tissue was found after the patient had left the procedural room and in the recovery unit.The doctor confirmed no post surgical complications and no bleeding was experienced by the patients involved with these two events.It was confirmed the physician was using the correct technique when using and removing the scope.The lead technician confirmed the cap was correctly applied to the distal end of the scope.No additional information is available for the (b)(6) 2021 event.The physician's and lead technician's opinion is the events are attributed to a cap issue.There are 4 complaints involved to capture the two patient events as follows: august event: (b)(6) is for the scope, tjf-q190v; (b)(6) is for the cap, maj-2315.July event: (b)(6) is for the scope, tjf-q190v; (b)(4) is for the cap, maj-2315.This is complaint 4 of 4.This report is for patient identifier (b)(6) for the july event involving the cap.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation and the results of the device history records (dhr) review.New information has been added to d8, d9, h3, h6, h7, h9 and h10.The device history records could not be reviewed because the lot number was not provided.Olympus ships products manufactured according to all applicable procedures and meet final product release criteria.The legal manufacturer performed a replication test using a test scope with a distal cover attached and pig organ.Removal of the test scope from the pig organ was experimented under two parameters "distal cover with/without slight crack" and "suction activated/not activated to remove the scope".The test result shows that tissue is embedded in the distal cover after the scope is removed with suction activated, which is observed regardless of "distal cover with/without slight crack".More tissue is embedded when small crack is present on the distal cover and suction is activated during removal.This could cause more severe damage to tissue.When there is no crack on the distal cover and suction is not activated, no tissue is embedded in the distal cover.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to suction being activated or the distal end of the scope is pushed against the mucous while removing the scope, a gap(space) can develop between forceps elevator and forceps channel, and between forceps elevator and the distal cover.Mucous can be trapped in the gap and damaged by the edge of the distal cover.It could lead to tissue injury, and tissue being embedded in the distal cover.Correction and preventative action (capa) investigation has been opened to further investigate this issue.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12461579
• MDR Text Key: 271105866
• Report Number: 8010047-2021-11634
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170403019
• UDI-Public: 04953170403019
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-2315
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2021
• 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: Initial
• Removal/Correction Number: Z-1292-2021
• Patient Sequence Number: 1
• Treatment: TJF-Q190V, SERIAL (B)(4); TJF-Q190V, SERIAL (B)(4)