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

Catalog Number M0063701190

Device Problems Mechanical Problem (1384); Device Slipped (1584); Device Operates Differently Than Expected (2913)

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

Event Date 09/11/2015

Event Type  malfunction  

Event Description

The forcep would not hold nor grasp according to surgeon.There was minimal delay to case to obtain another device.No harm to patient was noted.No excessive blood loss was noted.Manufacturer response for triceps hooked prong grasping forceps, triceps hooked prong grasping forceps (per site reporter): company replaced the product; we have not heard anything further back as of the date of this report.

• Brand Name: TRICEPS
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 5359772
• MDR Text Key: 35630259
• Report Number: 5359772
• 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: 11/12/2015,11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: M0063701190
• Device Lot Number: 17541106
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/12/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/12/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OCCURRED DURING: CYSTOSCOPY, RIGHT RETROGRADE PYEL
• Patient Age: 69 YR