MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORISE GEL; SUBMUCOSAL INJECTION AGENT

Catalog Number M06519221

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/07/2020

Event Type  malfunction  

Event Description

Gel tube syringe tip broke off during colonoscopy procedure.

• Brand Name: ORISE GEL
• Type of Device: SUBMUCOSAL INJECTION AGENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 9681247
• MDR Text Key: 178133479
• Report Number: 9681247
• Device Sequence Number: 1
• Product Code: PLL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/09/2020

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 Catalogue Number: M06519221
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/09/2020
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/07/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19710 DA