MAUDE Adverse Event Report: CAREFUSION INC. HENLY RETRACTOR SET

Model Number CH1030

Device Problem Insufficient Information (3190)

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

Event Date 03/12/2024

Event Type  malfunction  

Manufacturer Narrative

The henly retractor set subject of the reported was returned for evaluation.Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.

Event Description

The user facility reported that during a patient procedure, the blades to their henly retractor were not "locking on" and "sliding off" during use.User facility personnel stated the patient procedure was completed successfully and no injuries were reported.

• Brand Name: HENLY RETRACTOR SET
• Type of Device: HENLY RETRACTOR SET
• Manufacturer (Section D): CAREFUSION INC.; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION INC.; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 19086820
• MDR Text Key: 339989601
• Report Number: 1423507-2024-01011
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 10885403023064
• UDI-Public: 10885403023064
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CH1030
• Device Catalogue Number: CH1030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1