MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; LAPAROSCOPY KIT

Model Number ENDOPACK

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/03/2019

Event Type  malfunction  

Event Description

Prior to case, a small fleck of paper inside pack was identified on drape.Device pulled from service and a new pack without contamination was opened and used.

• Type of Device: LAPAROSCOPY KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1204 townline rd; 1 medline place; mundelein IL 60060
• MDR Report Key: 8775363
• MDR Text Key: 150557303
• Report Number: 8775363
• Device Sequence Number: 1
• Product Code: FDE
• 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: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ENDOPACK
• Device Catalogue Number: DYNJ53271C
• Device Lot Number: 19DBP816
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/05/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1