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

Model Number M0063701180

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 11/08/2016

Event Type  malfunction  

Event Description

Broke while opening and closing.

• Brand Name: TRICEP
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 6851377
• MDR Text Key: 85307154
• Report Number: 6851377
• Device Sequence Number: 1
• Product Code: FFL
• 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: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2018
• Device Model Number: M0063701180
• Device Lot Number: 18288323
• 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: 08/30/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR