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

Model Number SMA12LPKGR

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Date 03/22/2021

Event Type  malfunction  

Event Description

The surgical tech was setting up for the procedure and noticed a foreign object in the basin of a gyn laparoscopy pack.The foreign object appeared to be a small bug.The pack was wasted and supplies were replaced.

• Brand Name: CARDINAL HEALTH
• Type of Device: GYNECOLOGICAL LAPAROSCOPIC KIT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 11612760
• MDR Text Key: 243770471
• Report Number: 11612760
• 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: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SMA12LPKGR
• Device Catalogue Number: SMA12LPKGR
• Device Lot Number: 526167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1