MAUDE Adverse Event Report: AESCULAP AG CHALLENGER TI-P; CLIP, IMPLANTABLE

Model Number PL574T

Device Problems Material Protrusion/Extrusion (2979); Mechanical Jam (2983)

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

Event Date 07/09/2020

Event Type  malfunction  

Event Description

During robotic prostatectomy the challenger clip applier fired successfully for a full clip load and then two additional clips from the second reload when the applier froze.A piece of metal from the load was stuck in between the applier prongs.A new applier and second reload were obtained with same two successful fires then the applier froze with the metal protruding.Nothing fell into the patient.A new lot number reload was obtained and used successfully for remainder of case fires.The challenger clip applier and reloads are now and have been problematic for or staff.

• Brand Name: CHALLENGER TI-P
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): AESCULAP AG; 3773 corporate pkwy; center valley PA 18034
• MDR Report Key: 10288542
• MDR Text Key: 199248007
• Report Number: 10288542
• Device Sequence Number: 1
• Product Code: FZP
• 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: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL574T
• Device Catalogue Number: PL574T
• Device Lot Number: 52600083
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/09/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21900 DA