MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS SINGLE USE DISTAL COVER; ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM

Model Number MAJ-2315

Patient Problem Foreign Body In Patient (2687)

Event Date 09/06/2023

Event Type  Injury  

Event Description

Olympus disposable tip of endoscope came off during ercp (endoscopic retrograde cholangiopancreatography) procedure (part number maj-2315 -lot h2x21).The event was discovered after patient was in second phase recovery.Patient was taken back to the or (operating room), placed under anesthesia and an egd (esophagogastroduodenoscopy) and colonoscopy performed to retrieve the tip.Patient recovered well and was discharged after the retrieval.

• Brand Name: SINGLE USE DISTAL COVER
• Type of Device: ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS
• MDR Report Key: 17810530
• MDR Text Key: 324273193
• Report Number: MW5146115
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/20/2023

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
• Device Operator: Health Professional
• Device Model Number: MAJ-2315
• Device Lot Number: H2X21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2023
• Patient Sequence Number: 1
• Treatment: TJF-Q190V SERIAL # (B)(6) EVIS EXERA III SCOPE. THERAPY END DATE:; TJF-Q190V SERIAL # (B)(6) EVIS EXERA III SCOPE. THERAPY START DATE:
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White