MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ULTRASONIC PROBE

Model Number	UM-G20-29R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pancreatitis (4481); Cholangitis (4821)
Date of Event	02/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The literature article is attached for additional information.Doi.Org/10.1016/j.Gie.2023.02.005 provided for additional information.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Event or Problem Description
Olympus reviewed the literature titled "innovative method for the diagnosis of bile duct lesions using a novel tapered-tip sheath system to facilitate biliary biopsies." background and aims: pathologic evaluation of bile duct lesions is crucial for a definitive diagnosis and determination of an appropriate therapeutic strategy; however, current methods are limited by several challenges.This study evaluated the impact of a novel tapered-tip sheath system on biliary stricture diagnosis.Methods: this observational study evaluated 47 consecutive patients who underwent transpapillary biliary stricture biopsy using the novel tapered-tip sheath system from july 2020 to march 2022 compared with 51 historical control subjects undergoing conventional biopsies.Technical success rate, total biopsy time, number of biopsy specimens, adequate tissue sampling rate, adverse events, and diagnostic performance for biliary strictures were assessed.Results: the technical success rate was favorable in both groups, showing no significant difference (97.9% [46 of 47] vs 88.2% [45 of 51], p z.114).However, the total biopsy time was significantly shorter in the novel system group (3.7 vs 7.7 minutes, p <.001).The number of biopsy specimens did not differ between the groups; however, the novel system group had significantly more cases in which 3 tissue samples could be obtained (71.7% [33 of 46] vs 51.1% [23 of 45], p z.043), a higher adequate tissue sampling rate (88.2% vs 66.4%, p <.001), and fewer adverse events (6.4% vs 21.6%, p z.043).Although the diagnostic specificity of both groups was 100%, the novel system group had significantly higher diagnostic sensitivity and accuracy (82.1% vs 50% [p z.004] and 84.8% vs 55.5% [p z.005], respectively).Conclusions: the novel tapered-tip sheath system is a promising tool for biliary stricture diagnosis.Type of adverse events/number of patients: acute pancreatitis (mild=10, moderate=1, severe=2) cholangitis (1) there are three related patient identifiers: (b)(6) :tjf-260v (evis lucera duodenovideoscope) (b)(6) :chf-b260 (evis lucera ultrathin videoscope) (b)(6) :um-g20-29r (ultrasonic probe) this medwatch is for (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial and/or lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse events cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information received from the author b5.
Event or Problem Description
Additional information received from the author: the reported events were not caused by olympus products.

• Brand Name: ULTRASONIC PROBE
• Common Device Name: ULTRASONIC PROBE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18647900
• Report Number: 3002808148-2024-01118
• Device Sequence Number: 15250544
• Product Code: ITX
• UDI-Device Identifier: 04953170078668
• UDI-Public: 04953170078668
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K001203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2024

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: UM-G20-29R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2024
• Supplement Date Received by Manufacturer: 03/12/2024; 03/14/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 03/12/2024; 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CHF-B260 (EVIS LUCERA ULTRATHIN VIDEOSCOPE).; TJF-260V (EVIS LUCERA DUODENOVIDEOSCOPE).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown