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

Model Number MAJ-2315

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2023

Event Type  malfunction  

Manufacturer Narrative

This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.Additional information obtained identifies that no anti-fog agent was applied to the scope lens.The retrieved distal end was torn in half.During pre-use inspection, it was confirmed that the distal cover was not damaged, and it would not come off the scope.The subject device was not returned to an olympus service center for evaluation.Hence, a representative device (maj-2315/lot: h2311) was used to confirm the attachment according to the pre-use inspection procedure in the instruction manual, but the distal cover was not damaged.H4 device manufacturer date: date of manufacture cannot be determined since the lot number was not provided.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the legal manufacturer's investigation, since we have confirmed that the distal cover will not be damaged if it can be attached correctly according to the procedure in the instruction manual, it is likely that the damage to the distal cover was caused by the following handling by the user: by pushing the distal cover at an angle when attaching it to the scope, the distal cover was damaged.As a result of the operation confirmation, it was confirmed that if the distal cover is attached in the correct procedure, it will not be damaged.As a result of the labeling review, the instruction manual states that pushing diagonally when attaching to the endoscope is a handling factor that leads to the distal cover damage.According to additional information from the customer, it was confirmed that the distal cover was not damaged during the pre-use inspection, but since the distal cover of the actual product is damaged, this factor cannot be completely denied.As a result of the type test, we verified that "the distal cover does not break during use" in the evaluation at the development stage and confirmed that the product satisfies the specifications.In the parts manufacturer's inspection, after attaching the distal cover, push and pull loads are applied to the distal cover, and it is confirmed that there is no damage such as tearing or chipping in the distal cover.However, a definitive root cause could not be determined.The following information is stated in the ifu (instructions for use) which may help to prevent the issue: see caution column in 7.3: " push the center on the top of the distal cover.Otherwise, it may cause the break of the portion on the distal cover such as the tear off line." see warning column in 7.3: "detach the distal cover from the distal end of the endoscope when the distal cover cannot be attached to the endoscope smoothly or any incorrect attaching procedure is noticed.Refer to section 7.5: ¿detach the distal cover¿ for detaching the distal cover.With a new distal cover, repeat step 1 through 4.If the distal cover is not attached properly, it may slip off or fall off the distal end during the examination." olympus will continue to monitor field performance for this device.

Event Description

The customer reported that the distal cap was cracked.The reported issue was observed during a therapeutic endoscopic retrograde cholangiopancreatography (ercp) while extracting tjf-190v scope.Reportedly, no piece of the device fell into the patient¿s body.The intended procedure was completed using another device.The procedure was prolonged for 3-5 minutes.There was no patient or user injury reported due to the event.

• 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 Key: 17270750
• MDR Text Key: 319046195
• Report Number: 3003637092-2023-00147
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/06/2023

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 Number: MAJ-2315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/09/2023
• Initial Date FDA Received: 07/06/2023
• 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: Initial
• Patient Sequence Number: 1
• Treatment: TJF-190V DUODENOSCOPE