MAUDE Adverse Event Report: STRYKER CORP.; LIGHT, SURGICAL, CEILING MOUNTED

Model Number CZ499-06-04

Device Problems Material Separation (1562); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 07/29/2021

Event Type  malfunction  

Event Description

Berchtold light handle used for case was observed to be missing the green release button after the procedure.Green button has ability to dislodge from lumen of handle and become "free".This is a potential safety issue for retained surgical items.

• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): STRYKER CORP.; 5900 optical ct; san jose CA 95138
• MDR Report Key: 12293648
• MDR Text Key: 265584983
• Report Number: 12293648
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/30/2021

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
• Device Model Number: CZ499-06-04
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Weight: 101