MAUDE Adverse Event Report: CAREFUSION 2200, INC. / BD CAREFUSION LAPAROSCOPIC SCISSOR TIP; ELECTROSURGICAL CUTTING AND COAGULATION

Device Problem Defective Component (2292)

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

Event Date 02/06/2020

Event Type  malfunction  

Event Description

Defective piece of a carefusion brand disposable laparoscopic scissor tip was left in a reusable scissor handle and handle was processed in a lap chole set on (b)(6) 2020.On (b)(6) 2020 the lap chole set was opened for a case in room 1 and the defective product number: sp95.Product description: non-ratcheted handle.Lot number: unk.Quantity: 1.Bd complaint: pr (b)(4).The bd rep has reported the reusable scissor handle.

• Brand Name: CAREFUSION LAPAROSCOPIC SCISSOR TIP
• Type of Device: ELECTROSURGICAL CUTTING AND COAGULATION
• Manufacturer (Section D): CAREFUSION 2200, INC. / BD
• MDR Report Key: 9763674
• MDR Text Key: 181637538
• Report Number: MW5093322
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/11/2020

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: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1