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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) DREAMTOME¿ RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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BOSTON SCIENTIFIC - COSTA RICA (COYOL) DREAMTOME¿ RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00584050
Device Problem Device Packaging Compromised (2916)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Visual examination revealed that the pouch of the device was damaged (ruptured). The seals do not have damages. The complaint was consistent with the reported event that the seal was compromised. It is the most likely that the handle (finger ring) caused the failure noted, therefore, the most probable cause of this complaint is handling damage, since it is the most likely that the complaint was caused by handling of the device or portion of the device without direct patient contact either during unpacking, preparation, or shipping. A dhr (device history record) review was performed and no deviation was found. A search of the complaint database confirmed that no similar complaints exist for the specified batch.
 
Event Description
It was reported to boston scientific corporation that that the packaging of a dreamtome rx 44 was compromised. According to the complainant, during unpacking, the sterile packaging was found to be torn. Reportedly, there was no damage noted to the shipping box. There was no procedure involved and the device was not used in the patient. Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date. Should additional relevant details become available, a supplemental report will be submitted.
 
Manufacturer Narrative
The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown. (b)(4). Although the suspect device has been received, the evaluation has not been completed. Therefore, the cause of the reported malfunction has not been determined. Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that the packaging of a dreamtome rx 44 was compromised. According to the complainant, during unpacking, the sterile packaging was found to be torn. Reportedly, there was no damage noted to the shipping box. There was no procedure involved and the device was not used in the patient. Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date. Should additional relevant details become available, a supplemental report will be submitted.
 
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Brand NameDREAMTOME¿ RX 44
Type of DeviceUNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS
Manufacturer (Section G)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key7166189
MDR Text Key247972411
Report Number3005099803-2017-03971
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/05/2020
Device Model NumberM00584050
Device Catalogue Number8405
Device Lot Number21226679
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/06/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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