MAUDE Adverse Event Report: OLYMPUS AMERICA MEDICAL AND SURGICAL MANUFACTURING/ OLYMPUS SURGICAL TECHNOLOGIES AMERICA OLYMPUS ERCP DUODENOSCOPE (ELEVATOR SCOPE); DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	TJF-Q190V
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Bacteremia (4846)
Date of Event	05/07/2024
Type of Reportable Event	Death
Event or Problem Description
Available information at time of reporting reasonably suggests that there are four (4) potential patients directly impacted by one suspected medical device.Patients underwent procedures involving the same individual suspected medical device between (b)(6) 2024.Below is narrative for patient #1 (patient corresponding to this form's section a).For patients #2 - #4.Patient was admitted to hospital on (b)(6) 2024 for an endoscopic retrograde cholangiopancreatography (ercp) procedure with suspected medical device for removal of a stent previously placed in (b)(6) 2023.Patient had a past medical history of untreated stage iv lung cancer, pancreatic adenocarcinoma, and gero and was on palliative cares at an assisted living facility for multiple malignancies.The procedure was unable to replace stents after 2 hours of attempts to advance duodenoscope.Patient was discharged the same day.Patient had an informational visit with hospice on (b)(6) 2024 with plans to transition to home hospice.Patient was then admitted (b)(6) 2024 for worsening abdominal pain and underwent lnterventional radiology (ir) cholangiography and permanent stenting of a malignant stricture of the common bile duct on (b)(6) 2024.Patient had improving abdominal pain and was discharged on (b)(6) 2024.On (b)(6) 2024, patient was admitted for acute metabolic encephalopathy and septic shock.Patient had been set to admit to hospice at assisted living facility on (b)(6) 2024, but plans changed due to her returning to the hospital.Blood culture on admission was positive for carbepenamase-producing carbepenem resistant e.Coli (cp-cre) and klebsiella pneumoniae.Family approved no escalation of cares beyond iv antibiotics and fluids.Patient passed away on (b)(6) 2024.On (b)(6) 2024, ercp procedure involving suspected medical device was identified as possible link between multiple cp-cre infections.On 8/21/2024, suspected medical device was examined by borescope during facility investigation.Borescope revealed a small tear within the inner sheath of the device.As of time of this report, it is unknown when tear appeared on scope, what caused it, and whether it was present for ercp procedures involving affected patients.

• Brand Name: OLYMPUS ERCP DUODENOSCOPE (ELEVATOR SCOPE)
• Common Device Name: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): OLYMPUS AMERICA MEDICAL AND SURGICAL MANUFACTURING/ OLYMPUS SURGICAL TECHNOLOGIES AMERICA; bartlett TN
• MDR Report Key: 20156426
• Report Number: 20156426
• Device Sequence Number: 13772505
• Product Code: FDT
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/05/2024
• Report Date (Section F): 09/05/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: TJF-Q190V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/21/2024
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALLIANCE II 60ML SYRINGE / GAUGE ASSEMBLY ; CRE FIXED WIRE ESOPHAGEAL BALLOON DILATION CATH 6F; CRE PRO WG 18-19-20MM X 240CM; HYDRA JAGWIRE ST 260 STRAIGHT TIP 0.032IN; RESCUE RAT TOOTH/ALLIGATOR GRASP FORCEP 8X230MM; RX ACCESSORY RAPID REFILL CONT INJ SYSTEM ; SENSATION SHORT THROW SNARE MEDIUM OVAL FLEXIBLE 27MM
• Outcome Attributed to Adverse Event: Death
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 09/05/2024