MAUDE Adverse Event Report: V. MUELLER/ BECTON, DICKINSON AND COMPANY IRIS SCISSOR

Model Number OP5525

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems Abscess (1690); Unspecified Infection (1930)

Event Date 02/25/2018

Event Type  Injury  

Event Description

Patient having i and d on fifth finger.While md doing dissection the tip of the iris scissor broke off in the patient.The md found the tip and removed it.Abscess of finger of the left hand.I and d by md in office on (b)(6) 2018.No improvement.Sent to hospital on (b)(6) 2018 and admitted for iv antibiotics and betadine soaks.Infection not improving, difficulty moving finger.Surgery on (b)(6) 2018.

• Brand Name: IRIS SCISSOR
• Type of Device: IRIS SCISSOR
• Manufacturer (Section D): V. MUELLER/ BECTON, DICKINSON AND COMPANY; franklin lakes NJ 07417
• MDR Report Key: 7366057
• MDR Text Key: 103417908
• Report Number: MW5076050
• Device Sequence Number: 1
• Product Code: HNF
• Combination Product (y/n): N
• 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: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OP5525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 65