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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER GEMINI?; DISLODGER, STONE, BASKET, URETERAL, METAL
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BOSTON SCIENTIFIC - SPENCER GEMINI?; DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number M0063302080
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that during unpacking of the gemini basket, the complainant found that the sterile package containing the device was unsealed.There was no procedure nor patient involved.
 
Manufacturer Narrative
The device has been received for analysis.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
A visual assessment of the gemini basket packaging was performed and it was found that there was a hole in the clear packaging.The opening was straight, without any jaggedness, and was noted in the middle and top of the pouch, in a semi-linear fashion.The hole was approximately 9cm in length.A review of the device history record (dhr) was performed and revealed no issues.A search of the complaint database revealed that no similar complaints exist for the specified lot.Therefore, taking into consideration these factors and the analysis performed in the device packaging, the most probable root cause will be ¿handling damage¿.
 
Event Description
It was reported to boston scientific corporation that during unpacking of the gemini basket, the complainant found that the sterile package containing the device was unsealed.There was no procedure nor patient involved.
 
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Brand Name
GEMINI?
Type of Device
DISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - SPENCER
780 brookside drive
spencer IN 47460
Manufacturer (Section G)
BOSTON SCIENTIFIC - SPENCER
780 brookside drive
spencer IN 47460
Manufacturer Contact
ingrid matte
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key3710329
MDR Text Key4247390
Report Number3005099803-2014-01540
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 03/04/2014
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 Date01/07/2017
Device Model NumberM0063302080
Device Catalogue Number330-208
Device Lot Number16641941
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/18/2014
Initial Date FDA Received03/31/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/12/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/13/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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