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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DREAMTOME RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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BOSTON SCIENTIFIC CORPORATION DREAMTOME RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00584060
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/02/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
 
Event Description
Note: this report pertains to one of the two devices used during the same procedure.Refer to mfr report# 3005099803-2018-60199 for the first dreamtome and mfr report# 3005099803-2018-60204 for the second dreamtome.It was reported to boston scientific corporation that a dreamtome rx 44 was unpacked for an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during unpacking, it was noticed that there was a cotton-like material on the device.A second dreamtome was unpacked and the same cotton-like material was observed.The  procedure was completed with a third dreamtome rx 44.There were no user injury nor patient complications reported as a result of this event.
 
Manufacturer Narrative
Problem code 2944 captures the reportable event of foreign material present in the device.According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
 
Event Description
This report pertains to one of the two devices used during the same procedure.Refer to mfr report# 3005099803-2018-60199 for the first dreamtome and mfr report# 3005099803-2018-60204 for the second dreamtome.It was reported to boston scientific corporation that a dreamtome rx 44 was unpacked for an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during unpacking, it was noticed that there was a cotton-like material on the device.A second dreamtome was unpacked and the same cotton-like material was observed.Reportedly, there was no visible damage to the device packaging and the sterile barrier did not appear compromised.The  procedure was completed with a third dreamtome rx 44.There were no user injury nor patient complications reported as a result of this event.
 
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Brand Name
DREAMTOME RX 44
Type of Device
UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key7833404
MDR Text Key118880792
Report Number3005099803-2018-60204
Device Sequence Number1
Product Code KNS
UDI-Device Identifier08714729778288
UDI-Public08714729778288
Combination Product (y/n)N
PMA/PMN Number
K013153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/30/2021
Device Model NumberM00584060
Device Catalogue Number47401
Device Lot Number0022193764
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/02/2018
Initial Date FDA Received08/30/2018
Supplement Dates Manufacturer Received09/04/2018
Supplement Dates FDA Received10/01/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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