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

Model Number M00519220

Device Problems Break (1069); Insufficient Flow or Under Infusion (2182)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2022

Event Type  malfunction  

Event Description

While using the orise gel during the endoscopy, the glass syringe broke in my hand.It had about 3 cc left to use which we would have used had the syringe not broken.

• Brand Name: ORISE¿ GEL
• Type of Device: SUBMUCOSAL INJECTION AGENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 15224473
• MDR Text Key: 297881241
• Report Number: 15224473
• 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: 08/01/2022

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
• Device Model Number: M00519220
• Device Catalogue Number: M00519220
• Device Lot Number: 28984525
• 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: 08/01/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23360 DA
• Patient Sex: Male