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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORISE GEL; SUBMUCOSAL INJECTION AGENT
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BOSTON SCIENTIFIC CORPORATION ORISE GEL; SUBMUCOSAL INJECTION AGENT Back to Search Results
Device Problems Component Missing (2306); Device Contamination with Chemical or Other Material (2944); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/26/2022
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that orise gel was used during a polypectomy procedure performed on (b)(6) 2022.Prior to the procedure, it was observed that black liquid was present in the orise gel syringe.Additionally, the luer lock adaptor and tip cap was missing from the syringe.The procedure was completed with another orise gel device.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).
 
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Brand Name
ORISE GEL
Type of Device
SUBMUCOSAL INJECTION AGENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
business & technonlogy park
model farm road
cork
EI  
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key15474634
MDR Text Key305975225
Report Number3005099803-2022-05298
Device Sequence Number1
Product Code PLL
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 09/22/2022
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/29/2022
Initial Date FDA Received09/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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