MAUDE Adverse Event Report: AESCULAP AG CURVED IRIS SCISSORS 4 1/8"; SCISSORS, GENERAL, SURGICAL

Model Number BC061R

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2022

Event Type  malfunction  

Event Description

Curved iris scissors broke in the patient¿s nose while surgeon was performing nasal surgery.

• Brand Name: CURVED IRIS SCISSORS 4 1/8"
• Type of Device: SCISSORS, GENERAL, SURGICAL
• Manufacturer (Section D): AESCULAP AG
• MDR Report Key: 14976705
• MDR Text Key: 295770567
• Report Number: MW5110783
• Device Sequence Number: 1
• Product Code: LRW
• 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: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC061R
• Device Catalogue Number: BC061R
• Device Lot Number: 19063
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic