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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - COSTA RICA (COYOL) HYDRATOME¿ RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00583040
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The complainant was unable to provide the device lot number. Therefore, the manufacture and expiration dates are unknown. (b)(6). 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 a hydratome¿ rx 44 was unpacked. According to the complainant, during unpacking, it was noted that there was a hair inside the sealed packaging of the device. There was no procedure involved and the device was not used in the patient.
 
Manufacturer Narrative
Visual examination of the returned device on its original sealed pouch revealed that there was a hair found in the pouch on the sealed section. No other anomalies or damages were encountered. The complaint was consistent with the reported event of foreign matter inside the package. Based on the investigation and the receipt condition/functionality, the complaint conclusion investigation code selected for this complaint is "manufacturing execution error", since the manufacturing process was not executed as validated/as designed, once during the visual inspection a hair was found in the pouch on the seal section. An investigation has been initiated to address this issue. A dhr (device history record) review was performed and no deviation was found.
 
Event Description
It was reported to boston scientific corporation that a hydratome¿ rx 44 was unpacked. According to the complainant, during unpacking, it was noted that there was a hair inside the sealed packaging of the device. There was no procedure involved and the device was not used in the patient.
 
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Brand NameHYDRATOME¿ 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 Key7394581
MDR Text Key104425837
Report Number3005099803-2018-00960
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 03/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/29/2021
Device Model NumberM00583040
Device Catalogue Number8304
Device Lot Number21676539
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/30/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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