MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE MECHANICAL LITHOTRIPTOR V

Model Number BML-V232QR-30

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

Patient Problem Unspecified Hepatic or Biliary Problem (4493)

Event Date 03/31/2021

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported in the literature article titled ¿use of peroral cholangioscopy to screen for neoplastic bile duct lesions in patients with bile duct stones¿¿ patients experienced adverse events during/after procedures using olympus devices.Case with patient identifier (b)(6) reports tjv-q260v.Case with patient identifier (b)(6) reports bml-v232qr-30.Case with patient identifier (b)(6) reports gif-xp260n.Case with patient identifier (b)(6) reports gif-xp290n.Case with patient identifier (b)(6) reports fb-39q-1.Background and aims: although cholangiocarcinomas (ccas) can be diagnosed using several modalities, the detection of early-stage cancers remains unsatisfactory.We explored whether peroral cholangioscopy (poc) could be used to screen for neoplastic bile duct lesions including ccas in patients with bile duct stones.Methods: two hundred seven patients who underwent endoscopic removal of bile duct stones were enrolled between august 2010 and july 2018.The primary outcome was the detection rate of intraductal neoplastic biliary lesions by direct poc.Secondary outcomes were the technical success rates of direct poc and poc-guided forceps biopsy sampling (poc-fb), the diagnostic accuracy of the direct poc findings, adverse events, and the number needed to screen to detect a neoplastic bile duct lesion.Results: direct poc was successful in 199 of 207 patients (96.1%).Mild cholangitis developed in 2 patients (1.0%) and was treated conservatively.Of the 199 successfully performed pocs, 31 patients (15.6%) exhibited abnormal intraductal mucosal lesions.The technical success rate of poc-fb was 90.3% (28/31 patients).The pathologic diagnoses after poc-fb were ccas (n z 4), intraductal papillary neoplasms of the bile duct (ipn-b) (n z 2), an adenoma with dysplasia (n z 1), and benign lesions (n z 21).Direct poc correctly distinguished non-neoplastic from neoplastic bile duct lesions in 91.6% of patients.Curative surgical resection was performed for the 5 patients with ccas or ipn-b.The number needed to screen to detect a neoplastic bile duct lesion was 29.6.Conclusions: direct poc using a dedicated, ultraslim upper endoscope usefully screens for neoplastic bile duct lesions including ccas in selected patients with bile duct stones.Direct poc was technically successful in 199 of 207 patients (96.1%).Of those patients, 31 (15.6%) exhibited abnormal intraductal mucosal lesions (fig.1).Twenty-five patients (12.6%) had residual stones that were removed from 23 patients (92.0%) under direct visualization.Mild cholangitis developed in 2 of 207 patients (1.0%).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, correct the initial mdr, and provide the legal manufacturer's investigation.Correction: b1, h1 - based on the information provided by the author, the adverse events reported in the literature articles have been determined not to be serious injuries.The device history records (dhr) for this device could not be reviewed since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer was unable to determine the probable cause of the adverse events since the device was not returned for evaluation.No malfunctions were reported.Olympus will continue to monitor field performance for this device.

Event Description

Additional information received from the author: the olympus devices did not cause the adverse events reported in the article.No malfunctions occurred with olympus devices.The device is not available for return.

• Brand Name: SINGLE USE MECHANICAL LITHOTRIPTOR V
• Type of Device: SINGLE USE MECHANICAL LITHOTRIPTOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14734340
• MDR Text Key: 295035411
• Report Number: 8010047-2022-10254
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/11/2022

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: BML-V232QR-30
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 06/17/2022
• Supplement Dates Manufacturer Received: 07/13/2022
• Supplement Dates FDA Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other