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

Model Number SMA12LPKGS

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 11/22/2021

Event Type  malfunction  

Event Description

During set up for a procedure, the surgical tech found a black piece of debris in one of the raytecs from the cardinal custom pack - gyn laparoscopy pack.The entire table was replaced with new supplies.It did not reach the patient.

• 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: 12982979
• MDR Text Key: 282106003
• Report Number: 12982979
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SMA12LPKGS
• Device Catalogue Number: SMA12LPKGS
• Device Lot Number: 630103
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1