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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 Perforation (2001); Peritonitis (2252); Pancreatitis (4481); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/01/2023
Event Type  Injury  
Manufacturer Narrative
H6: component code appropriate term: crusher of stones.Health effect-clinical code appropriate term: elevation of c-reactive protein.The literature article is attached for additional information.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
 
Event Description
Olympus medical systems corp.(omsc) received a literature titled, "comparing endoscopic ultrasound-guided antegrade treatment and balloon endoscopy-assisted endoscopic retrograde cholangiopancreatography in the management of bile duct stones in patients with surgically altered anatomy: a retrospective cohort study".Endoscopic ultrasound-guided antegrade treatment (eus-ag) and balloon endoscopy-assisted endoscopic retrograde cholangiopancreatography (be-ercp) have emerged as useful procedures for managing bile duct stones (bds) in patients with surgically altered anatomy.However, the comparison between these two procedures has not been well studied.The aim of our study was to compare the clinical outcomes of eus-ag and beercp for managing bds in patients with surgically altered anatomy.Type of adverse events/number of patients: event1: bile peritonitis(n=3).Event2: elevation of c-reactive protein(n=1).Event3: pancreatitis (n=3).Event4: perforation (n=4).The following procedure and olympus devices are used in this literature.(1) eus-ag: convex-type eus scope (gf-uct260).Fine-needle aspiration (fna) needle (ez shot 3 plus : estimated as na-u200h-8019).Retrieval balloon catheter (multi-3 v plus : estimated as b-v232p-b).Ercp scope (tjf 260 or tjf 290).Mechanical lithotripsy (ml: lithocrushv : estimated as bml-v437qr-30).(2) be-ercp: 0.025-inch guidewire (visiglide 2).Extraction balloon (multi-3 v plus).Lithocrushv.Ultra-slim endoscope (gif-xp260n or gif-xp290n).The following events have been reported in the literature: (refer to table 3 of the literature).Event1: bile peritonitis(n=3) : occurred in eus-ag.Event2: elevation of c-reactive protein (n=1) : occurred in eus-ag.Event3: pancreatitis (n=3) : occurred in be-ercp.Event4: perforation (n=4) : occurred in be-ercp.Three patients with perforation after be-ercp experienced severe adverse events, necessitating surgery in one and clip closure in two.A moderate case occurred in one patient with bile peritonitis after eus-ag who required an additional procedure using be-ercp to place an endoscopic nasobiliary drainage.This event requires eight reports with patient identifiers: - devices used for eus-ag and be-ercp: (1) (b)(4).B-v232p-b (event 1,2,3,4): (2) (b)(4).Bml-v437qr-30 (event 1,2,3,4): - devices used for eus-ag: (3) (b)(4).Gf-uct260 (event 1,2).(4) (b)(4).Na-u200h-8019 (event 1,2).(5) (b)(4).Tjf-260v (event 1,2).(6) (b)(4).Tjf-q290v (event 1,2).- devices used for be-ercp: (7) (b)(4).Gif-xp260n (event 3,4).(8) (b)(4).Gif-xp290n (event 3,4).This report is for (b)(4).
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide additional information received from the author.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.In addition, based on the clinical/medical evaluation and risk assessment, it is possible that the reported event is an accident, or a complication associated with a procedure using the subject device.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.
 
Event Description
Additional information received from the author confirms this event was not caused by an olympus device and there is no malfunction in olympus 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 Key17877905
MDR Text Key325007761
Report Number9614641-2023-01468
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,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/02/2023
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/14/2023
Initial Date FDA Received10/05/2023
Supplement Dates Manufacturer Received10/30/2023
Supplement Dates FDA Received11/02/2023
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
Patient Outcome(s) Required Intervention;
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