MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. OES CHOLEDOCHO FIBERSCOPE

Model Number CHF-P60

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 08/11/2023

Event Type  Death  

Manufacturer Narrative

Since the literature described "5 mm choledochoscope", olympus selected "chf-p60" as a representative product.The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

Olympus reviewed the following literature titled "laparoscopic common bile duct exploration with primary closure could be safely performed among elderly patients with choledocholithiasis".Background: for patients with choledocholithiasis, laparoscopic common bile duct exploration (lcbde) is preferred over open surgery.Whether primary closure of the common bile duct (cbd) should be performed upon completion of choledochotomy remains unclear, and the corresponding indications for primary closure of the common bile duct have yet to be fully identified.This study was performed to evaluate the safety and feasibility of primary closure of cbd among elderly patients (= 70 years) after lcbde.Methods: patients with choledocholithiasis who had undergone lcbde with primary closure of the cbd between (b)(6) 2014 and (b)(6) 2020 were retrospectively reviewed.Included patients were assigned into two groups (group a: =70 years and group b: <70 years) according to age.Group a was compared with group b in terms of preoperative characteristics, intraoperative results and postoperative outcomes.Results: the mean operative time for group a was 176.59 min (± 68.950), while the mean operative time for group b was 167.64 min (± 69.635) (p = 0.324).The mean hospital stay after surgery for group a was 8.43 days (± 4.440), while that for group b was 8.30 days (± 5.203) (p = 0.849).Three patients in group a experienced bile leakage, while bile leakage occurred in 10 patients in group b (3.8% vs.4.5%, p = 0.781).Group a was not significantly different from group b in terms of postoperative complications and 30-day mortality except pneumonia (p = 0.016), acute cardiovascular event (p = 0.005) and icu observation (p = 0.037).After a median follow-up time of 60 months, 2 patients in group a and 2 patients in group b experienced stone recurrence (2.5% vs.0.9%, p = 0.612).One patient in group a experienced stenosis of the cbd, while stenosis of the cbd occurred in 5 patients in group b (1.3% vs.2.2%, p = 0.937).Conclusions: primary closure of cbd upon completion of lcbde could be safely performed among patients = 70 years.Type of adverse events/number of patients.Blood transfusion - 4 patients.Icu observation - 10 patients.Remnant stone - 13 patients.Recurrent stone - 4 patients.Bile leakage - 13 patients.Cbd stricture - 6 patients.Pneumonia - 9 patients.Acute cardiovascular event - 4 patients.Intra-abdominal hemorrhage - 4 patients.Fever - 20 patients.Urinary retention - 1 patient.30-day mortality - 1 patient.This literature article requires 2 reports.The related patient identifiers are as follows: -(b)(6) : chf-p60 oes choledocho fiberscope for patient death.-(b)(6) : chf-p60 oes choledocho fiberscope for other adverse events.This medwatch report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the author (see b5).

Event Description

Additional information received from the author: in the medical opinion of the author, the olympus device did not cause malfunction nor the adverse events reported.

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 event 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.

• Brand Name: OES CHOLEDOCHO FIBERSCOPE
• Type of Device: CHOLEDOCHO FIBERSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17758548
• MDR Text Key: 323535501
• Report Number: 9610595-2023-13434
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K843084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: CHF-P60
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/15/2023
• Supplement Dates Manufacturer Received: 09/18/2023; 09/29/2023
• Supplement Dates FDA Received: 09/19/2023; 10/17/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death