MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RIGID SIDEKICK; ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY

Model Number 890-304

Device Problem Bent (1059)

Patient Problem No Information (3190)

Event Date 07/03/2017

Event Type  malfunction  

Event Description

The needle bent inside the urethra.

• Brand Name: RIGID SIDEKICK
• Type of Device: ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 6759756
• MDR Text Key: 81602533
• Report Number: 6759756
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 890-304
• Device Catalogue Number: 890-304
• Device Lot Number: 100098672
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/18/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 43 YR