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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) RADIAL JAW? 3; FORCEPS, BIOPSY, NON-ELECTRIC
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BOSTON SCIENTIFIC - COSTA RICA (COYOL) RADIAL JAW? 3; FORCEPS, BIOPSY, NON-ELECTRIC Back to Search Results
Model Number M00515361
Device Problem Packaging Problem (3007)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/31/2014
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a radial jaw 3 biopsy forceps was opened to be used in the stomach during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2014.According to the complainant, during unpacking, the physician found the packaging was damaged.Additionally it was not sealed and the sterile barrier was compromised.No issue with the device was reported and the procedure was completed with another of the same device.Reportedly, there were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be "stable.".
 
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 medwatch will be filed.
 
Manufacturer Narrative
Visual evaluation of the returned pouch received was found to be opened at the seal that is expected to be opened by the customer to access the device.This seal presented evidence that the sealing process was performed.The lateral and bottom seals were intact.The returned device presented evidence indicating use or handling.Visually, the distal end of the device revealed one of the jaw/cup to be broken and the device coil was found to be elongated.Further analysis found no irregularities along the sealed marks on the packaging.The complaint was not consistent with the reported event of sterile barrier compromised.Additionally, the device presented evidence of use or handling.The review and analysis of all available information and the returned device fails to indicate a root cause or probable root cause.Therefore, the root cause classification "undeterminable" is selected for this complaint.There is an investigation in place to address this issue.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.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 a radial jaw 3 biopsy forceps was opened to be used in the stomach during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2014.According to the complainant, during unpacking, the physician found the packaging was damaged.Additionally it was not sealed and the sterile barrier was compromised.No issue with the device was reported and the procedure was completed with another of the same device.Reportedly, there were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be "stable.".
 
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Brand Name
RADIAL JAW? 3
Type of Device
FORCEPS, BIOPSY, NON-ELECTRIC
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 Key4272256
MDR Text Key5294882
Report Number3005099803-2014-03741
Device Sequence Number1
Product Code FCL
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/31/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date01/14/2016
Device Model NumberM00515361
Device Catalogue Number1536
Device Lot Number15793734
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/09/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/15/2013
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 Age40 YR
Patient Weight80
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