MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SEGURA HEMISPHERE; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number M0063801100

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 11/25/2020

Event Type  malfunction  

Event Description

Basket not functional upon removing from package.

• Brand Name: SEGURA HEMISPHERE
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11130729
• MDR Text Key: 225517810
• Report Number: 11130729
• Device Sequence Number: 1
• Product Code: NQU
• UDI-Device Identifier: 08714729341925
• UDI-Public: (01)08714729341925(17)231023(10)026238022
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/17/2020

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 Model Number: M0063801100
• Device Lot Number: 026238022
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/07/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26280 DA
• Patient Weight: 95