MAUDE Adverse Event Report: AESCULAP DUROTIP DISSECTING SCISSORS

Catalog Number BC559R

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

Patient Problem No Information (3190)

Event Date 12/04/2017

Event Type  Injury  

Event Description

A (b)(6) female patient underwent left total hip replacement.During procedure, it was noted that two pieces of the long mayo scissors had broken off.Diagnostic imaging was utilized to successfully retrieve both pieces.Rest of procedure concluded uneventfully and patient was subsequently discharged home.

• Brand Name: DUROTIP DISSECTING SCISSORS
• Type of Device: DUROTIP DISSECTING SCISSORS
• Manufacturer (Section D): AESCULAP; center valley PA 18034
• MDR Report Key: 7142072
• MDR Text Key: 95743443
• Report Number: MW5074175
• Device Sequence Number: 1
• Product Code: HRR
• 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: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BC559R
• Was Device Available for Evaluation?: Yes
• 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): Hospitalization; Required Intervention
• Patient Age: 52 YR