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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE MECHANICAL LITHOTRIPTOR V

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AOMORI OLYMPUS CO., LTD. SINGLE USE MECHANICAL LITHOTRIPTOR V Back to Search Results
Model Number BML-V437QR-30
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypoxia (1918); Perforation (2001); Pancreatitis (4481)
Event Date 07/27/2021
Event Type  Injury  
Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
 
Event Description
Olympus reviewed the following literature titled, "balloon enteroscopy-assisted endoscopic retrograde cholangiopancreatography for the treatment of common bile duct stones in patients with roux-en-y gastrectomy: outcomes and factors affecting complete stone extraction." this retrospective study investigated the treatment outcomes and potential factors affecting complete stone extraction in 79 patients.The initial success rates of reaching the papilla of vater, biliary cannulation, and biliary intervention, including complete stone extraction or biliary stent placement, were 92%, 81%, and 78%, respectively.The multivariate analysis indicated that the largest cbd diameter = 14 mm (odds ratio (or), 0.04; 95% confidence interval (ci), 0.01¿0.58) and retroflex position (or, 6.43; 95% ci, 1.12¿36.81) were independent predictive factors affecting complete stone extraction achievement.This study concludes that therapeutic sdbe-ercp for cbd stones in a relatively elderly ryg cohort, was effective and safe.Type of adverse events/number of patients mild perforation - 1 patient moderate perforation - 1 patient mild pancreatitis - 1 patient mild hypoxia - 1 patient this was a multi-center retrospective study conducted in three tertiary hospitals.This literature article requires 8 reports.The related patient identifiers are as follows: (b)(6)/pr-v220q/ae, (b)(6)/kd-10q-1/ae, (b)(6)/fg-v425pr/ae, (b)(6)/bml-v437qr-30/ae, (b)(6)/pr-v220q/hypoxia for 83-year-old, (b)(6)/kd-10q-1/hypoxia for 83-year-old, (b)(6)/fg-v425pr/hypoxia for 83-year-old, (b)(6)/bml-v437qr-30/hypoxia for 83-year-old.This medwatch 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 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.This supplemental report includes a correction to g2 to provide information that was inadvertently not included on the initial medwatch.Olympus will continue to monitor field performance for this device.
 
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Brand Name
SINGLE USE MECHANICAL LITHOTRIPTOR V
Type of Device
SINGLE USE MECHANICAL LITHOTRIPTOR
Manufacturer (Section D)
AOMORI OLYMPUS CO., LTD.
2-248-1 okkonoki
kuroishi-shi, aomori 036-0 357
JA  036-0357
Manufacturer (Section G)
AOMORI OLYMPUS CO., LTD.
2-248-1 okkonoki
kuroishi-shi, aomori
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key16127150
MDR Text Key306977972
Report Number9614641-2023-00023
Device Sequence Number1
Product Code LQC
UDI-Device Identifier04953170218415
UDI-Public04953170218415
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
CLASS2-EXMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Study,Literature,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/23/2023
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 NumberBML-V437QR-30
Device Lot NumberUNKNOWN(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 12/11/2022
Initial Date FDA Received01/09/2023
Supplement Dates Manufacturer Received01/11/2023
Supplement Dates FDA Received01/23/2023
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 Number1
Treatment
NON-OLYMPUS: ENTEROSCOPE EI-530B OR EI-580BT; NON-OLYMPUS: SPHINCTEROTOME (ROTACUTII)
Patient Outcome(s) Required Intervention; Other;
Patient Age83 YR
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