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

Model Number	MAJ-2315
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Laceration(s) of Esophagus (2398)
Date of Event	08/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after the endoscopic retrograde cholangiopancreatography was completed, while the duodenoscope was being withdrawn, the single-use disposable protective cover on the distal tip ruptured, causing an esophageal injury with bleeding.As a result of this complication, endoscopic intervention was required, involving the application of clips to close the injury and control the bleeding.It was noted that the same incident occurred in two patients on separate days using the same lot number.The patients required one additional day of hospitalization.This report is 1 of 2 patients involved.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.

• Brand Name: SINGLE USE DISTAL COVER
• Common Device Name: 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 ; +1(508)207-7661
• MDR Report Key: 50872667
• Report Number: 3003637092-2026-00186
• Device Sequence Number: 9380347
• Product Code: FDT
• UDI-Device Identifier: 04953170441271
• UDI-Public: 04953170441271
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K253646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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
• Operator of Device: Health Professional
• Device Model Number: MAJ-2315
• Device Lot Number: H5Z26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown