MAUDE Adverse Event Report: BOSTON SCIENTIFIC BOSTON SCIENTIFIC TRICEP NON-RETRACTING; HOOKED - PRONG GRASPING FORCEPS 3.0F

Model Number GTIN 08714729192237

Device Problems Difficult to Remove (1528); Component Missing (2306); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/16/2015

Event Type  malfunction  

Event Description

Boston scientific tricep non-retracting hooked-prong grasping forceps to retrieve kidney stone on the left side of patient.Prior to use full inspection complete noted to be intact and in working order.When forcep removed from patient, tips of forcep missing.After internal and external exam performed by doctor, unable to visualize or retrieve tips of forceps.

• Brand Name: BOSTON SCIENTIFIC TRICEP NON-RETRACTING
• Type of Device: HOOKED - PRONG GRASPING FORCEPS 3.0F
• Manufacturer (Section D): BOSTON SCIENTIFIC; 780 brookside dr.; spencer IN 47460
• MDR Report Key: 5361077
• MDR Text Key: 35802648
• Report Number: MW5059256
• Device Sequence Number: 1
• Product Code: FFL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: GTIN 08714729192237
• Device Catalogue Number: M0063701190
• Device Lot Number: 18026534
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR