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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORPORATION SINGLE USE ROTATABLE CLIP FIXING DEVICE

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OLYMPUS MEDICAL SYSTEM CORPORATION SINGLE USE ROTATABLE CLIP FIXING DEVICE Back to Search Results
Model Number HX-201UR-135L.A
Device Problems Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 03/17/2014
Event Type  Injury  
Manufacturer Narrative
The device reference in this report has been discarded by the user facility and will not be returned to olympus for evaluation.The exact cause of the user's experience could not be conclusively determined at this time.If additional information becomes available at a later time, this report will be supplemented.
 
Event Description
Olympus was informed that during an esophagogastroduodenoscopy (egd) procedure, the clips were prematurely closing and the physician had difficulty deploying the clip through the sheath, as it was taking two hands to close the clip.It was noted that during the end of the egd procedure, before the clip exchange, the pt began to bleed severely.The clips were exchanged and the procedure was completed using another device.The pt was transported to the hospital and was admitted for a 4-5 days for an inpatient stay and was given 2 units of blood.No further information has been provided as to the current status of the pt at this time.
 
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Brand Name
SINGLE USE ROTATABLE CLIP FIXING DEVICE
Type of Device
SINGLE USE ROTATABLE CLIP
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEM CORPORATION
2951 ishikawa-cho
hachioji-shi, tokyo 192- 8507
JA  192-8507
Manufacturer (Section G)
OLYMPUS MEDICAL SYSTEM CORPORATION
2951 ishikawa-cho
hachioji-shi, tokyo 192- 8507
JA   192-8507
Manufacturer Contact
noemi schambach
2400 ringwood ave.
san jose, CA 95131
4089355002
MDR Report Key3767363
MDR Text Key15881773
Report Number2951238-2014-00142
Device Sequence Number1
Product Code MND
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K984255
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/18/2014
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 NumberHX-201UR-135L.A
Device Catalogue NumberHX-201UR-135L.A
Device Lot Number31K
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/18/2014
Initial Date FDA Received04/03/2014
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; Other; Required Intervention;
Patient Age67 YR
Patient Weight109
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