MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; GYNECOLOGICAL LAPAROSCOPIC KIT

Model Number SMA12TIKGS

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

Event Date 01/24/2024

Event Type  malfunction  

Event Description

Operating room reports that a lithotomy pack was opened for urology case.Count initiated by circulator and scrub tech.Scrub tech removed paper tab from raytecs and counted 9 raytecs.Count was repeated 2 more times and the table was searched.The missing raytec was not in the pack.The 9 raytecs were removed from the field by the circulator and new raytecs were opened.Circulator and scrub tech performed a new count, and it had the correct number of raytecs (10).

• Brand Name: CARDINAL HEALTH
• Type of Device: GYNECOLOGICAL LAPAROSCOPIC KIT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 18902091
• MDR Text Key: 337633852
• Report Number: 18902091
• Device Sequence Number: 1
• Product Code: OHD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SMA12TIKGS
• Device Catalogue Number: SMA12TIKGS
• Device Lot Number: 192623
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/21/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1