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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE BALLOON DILATOR V (WITH KNIFE)

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE BALLOON DILATOR V (WITH KNIFE) Back to Search Results
Model Number BD-VC431Q-1240-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pancreatitis (4481)
Event Type  Injury  
Manufacturer Narrative
The subject device had been discarded at the facility, and it did not return for investigation. Therefore, the phenomenon of the reported event could not be confirmed. The manufacturing record was reviewed and found no irregularities. Since the subject device could not be confirmed and dhr presented no abnormalities, the exact cause of the reported event could not be determined. Therefore, it was not identified whether pancreatitis was caused by the actual product or not. Based on the past cases, it is possible that the balloon was ruptured. It can be inferred that the forceps elevator was raised excessively, or the device was moved back and forth when the balloon was not completely deflated. The balloon was possibly rubbed from the effect of contacting a metal area of the endoscope, causing deflation of the balloon. The above device handling about deflation of the balloon has been warned in the instruction manual. A supplemental report will be submitted if additional or significant information becomes available at a later time.
 
Event Description
Olympus medical systems corp. (omsc) received the following report from the user. During a duodenal papilla incision, the subject device was used. After the user incised the duodenal papilla with the cutting wire of the subject device, the balloon of the subject device could not inflate. The intended procedure was completed with the competitor's device. At a later date, the user confirmed that the patient had been diagnosed with pancreatitis. The causal relationship with our products is unknown. No further information was provided. Omsc will submit one medical device reports (mdr) of the subject device for postoperative pancreatitis.
 
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Brand NameSINGLE USE BALLOON DILATOR V (WITH KNIFE)
Type of DeviceBALLOON DILATOR
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 Key11830725
MDR Text Key250796977
Report Number8010047-2021-06391
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K193039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 05/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberBD-VC431Q-1240-20
Device Lot Number03K
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/19/2021
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 Treatment Data
Date Received: 05/17/2021 Patient Sequence Number: 1
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