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

Model Number MAJ-2315

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/18/2023

Event Type  malfunction  

Event Description

The olympus sales representative reported (on behalf of the customer) that while placing a scope through the bite block, the distal end cover of the single use distal cover fell off the scope (during the withdrawal of the scope through the bite block) and into the patient¿s mouth.The distal cover was retrieved with the user¿s finger.The issue occurred during the diagnostic procedure, and the procedure was completed.There was no patient harm associated with the event.

Manufacturer Narrative

The device was discarded and will not be returned for evaluation.This report is related to linked patient identifier (b)(6).And submitted medwatch 129287.The following details are based on the legal manufacturer's investigation: this report is being supplemented to provide additional information based on the legal manufacturer's final investigation.(b)(4) has undergone a design change under capa no.(b)(4).(lot no.H2530 and later are design change products).Since the actual product lot is h2107, this complaint is a pre-design change product.Since the actual product has not been returned, we performed a reproduction check using a representative device (b)(4)/lot: h2311 according to the procedure in the instruction manual, but the indicated phenomenon was not reproduced.In addition, as a result of product standards test using a representative device (b)(4) lot: h2311 against the resistance quality standard that "does not come off from the end of the scope during use", the device satisfies the product standard.During the development stage, quality evaluations were conducted using mass production prototypes, and it was verified that "the distal cover does not come off from the endoscope during use." the parts supplier conducts sampling inspections of 3 parts for each production lot and confirms that the parts conform to the specifications.It was confirmed via the dhr (device history record) of the relevant lot (h2107), but there was no non-conformity related to the indicated defect phenomenon.The event can be detected/prevented by following the instructions for use which state: "7.3 attaching the distal cover" (p.11 to p.13), please make sure that the distal cover is intact without any problem before installation, and it has no damage(crack) after installation.Also, do not use anti-fog agents as it is known that anti-fog agents will damage the cover.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.An interview was conducted by olympus with the facility as part of the root cause investigation per capa-200735.Correction to initial for information inadvertently left out.The customer was unable to dedicate time to demonstrating how they attach the distal cover to the endoscope.However, they have never noticed a defect/damage on the distal cover before attaching it.They stated there is no difficulty in the attachment process.It was reported that the facility currently uses the new design of the distal cover (ma j-2315).To prevent the detachment of the distal cover from recurring, the following information was confirmed during the interview: -the facility educates all personnel involved with attaching the distal cover before or during the procedure.They do not ask the personnel who attaches the distal cover to follow the instruction manual, but provides user guide after training.-implemented a new workflow that doctors inspect the distal cover before their ercp cases.Notifies staff to always check the distal cover is still on right after scoping out.Furthermore, it was confirmed by the facility the distal cover is stored in multiple storage rooms.They receive distal cover without the box and it is stored in the trolley.The trolley is brought to operating room and the distal cover is picked up from the trolley and attached to the endoscope.They are using omnibloc from gi supply inc.Correction to h10 investigation results: based on the investigation, the possible causes for the drop off of maj-2315 are presume to be the following: -the cover was easily removed from the scope due to insufficient attachment to the scope.-when the cover was attached to the scope, the cover was damaged by pushing it diagonally, making it easy for the cover to come off the scope.Correction to h6 investigation and findings codes.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16371792
• MDR Text Key: 309595348
• Report Number: 3003637092-2023-00059
• 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: K220587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 07/18/2023

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
• Device Lot Number: H2107
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2023
• Initial Date FDA Received: 02/14/2023
• Supplement Dates Manufacturer Received: 06/21/2023
• Supplement Dates FDA Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2022
• 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-Q190V
• Patient Sex: Unknown