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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE MECHANICAL LITHOTRIPTOR V Back to Search Results
Model Number BML-V437QR-30
Device Problem Difficult to Remove (1528)
Patient Problems Perforation (2001); Foreign Body In Patient (2687)
Event Date 09/02/2021
Event Type  Injury  
Manufacturer Narrative
The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.The lot number of the subject device is unknown.As a result of checking the manufacturing record for past one year from the event date, it was found no irregularities.This event has already occurred in the past.Based on the result of a previous similar complaint investigation, it is possible to predict the cause of the reported event.Therefore, it was determined that the investigation by using equipments of similar structure or similar equipments was not necessary.Due to various factors such as the size, hardness or shape of the calculus, a load beyond the resistance strength might have applied to the product during the lithotripsy.As a result, the operating wire was possibly broken.The above device handling has warned in the instruction manual as follows.*a lithotriptor cannot always crush all calculi captured in the basket.Operation of this instrument is based on the assumption that open surgery is possible as an emergency measure.If the calculus is too hard, it is possible that the damages shown in chapter 5, ¿emergency treatment¿ may occur.Use the lithotriptor by considering that it may lead to damaging the instrument and that open surgery may have to take place.
 
Event Description
Olympus medical systems corp.(omsc) was informed by the health professional that during a cholelithotripsy using the subject device the following event occurred.The operating wire was broken off near the middle of it.Because the breakage of the device wire was near the forceps port of the endoscope, the operator felt resistance to removing the endoscope from the patient, and perforation occurred in the duodenum during considering how to deal with it.The procedure was interrupted and emergency surgery was performed.The perforation was treated by omental implantation repair, and the surgery was completed.After the surgery, the patient was hospitalized.The patient is doing well.
 
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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 Key12479341
MDR Text Key271894862
Report Number8010047-2021-11809
Device Sequence Number1
Product Code LQC
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 health professional,user faci
Reporter Occupation Physician
Type of Report Initial
Report Date 09/16/2021
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? Yes
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 09/03/2021
Initial Date FDA Received09/16/2021
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) Hospitalization; Required Intervention;
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