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

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Olympus was informed of two events in which patients sustained a tissue damage when a duodenovideoscope was being withdrawn.The procedure performed was an endoscopic retrograde cholangiopancreatography (ercp) to treat common bile duct (cbd) stones.Hold kc 02.15.The patients required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.

• 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: 16337161
• MDR Text Key: 310125424
• Report Number: 3003637092-2023-00036
• 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: 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 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
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 02/09/2023
• 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 Number: Z-1292-2021
• Patient Sequence Number: 1
• Treatment: TJF-Q190V, SERIAL NUMBER UNKNOWN
• Patient Sex: Unknown