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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) AUTOTOME¿ RX 39 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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BOSTON SCIENTIFIC - COSTA RICA (COYOL) AUTOTOME¿ RX 39 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00545190
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
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 an autotome¿ rx 39 was included in an inventory count. According to the complainant, a substance was noticed on the autotome¿ rx 39 catheter. Reportedly, there was no visible damage noted on the packaging. There were no procedure nor patient involved in this event.
 
Event Description
It was reported to boston scientific corporation that an autotome rx 39 was included in an inventory count. According to the complainant, a substance was noticed on the autotome rx 39 catheter. Reportedly, there was no visible damage noted on the packaging. There were no procedure nor patient involved in this event.
 
Event Description
It was reported to boston scientific corporation that an autotome rx 39 was included in an inventory count. According to the complainant, a substance was noticed on the autotome rx 39 catheter. Reportedly, there was no visible damage noted on the packaging. There were no procedure nor patient involved in this event.
 
Manufacturer Narrative
A visual examination of the returned device within the original pouch revealed that there was a foreign matter in the extrusion working length. No others defects were noted. The complaint is consistent with the returned device that the device has a foreign matter. Based the available/gathered information and the inspection performed to the returned product, manufacturing execution error was selected as the most probable cause, since the manufacturing process was not executed as validated/as designed as foreign matter was observed in the extrusion working length into the sealed pouch. An investigation has been initiated to address this issue. 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.
 
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Brand NameAUTOTOME¿ RX 39
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
MDR Report Key7649266
MDR Text Key112715349
Report Number3005099803-2018-02094
Device Sequence Number1
Product Code KNS
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,Followup
Report Date 06/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/26/2019
Device Model NumberM00545190
Device Catalogue Number4519
Device Lot Number19765728
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2018
Is This a Reprocessed and Reused Single-Use Device? No

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