MAUDE Adverse Event Report: AESCULAP AESCULAP; CLIP, IMPLANTABLE

Model Number PL574T

Device Problems Component Falling (1105); Material Fragmentation (1261)

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

Event Date 04/18/2018

Event Type  malfunction  

Event Description

Aesculap clip reload fell off applier into patient.All pieces were accounted for and removed.No patient injury.New reload inserted in clip applier without problem.No further information available.

• Brand Name: AESCULAP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): AESCULAP; 3773 corporate pkwy; center valley PA 18034
• MDR Report Key: 7537001
• MDR Text Key: 109096682
• Report Number: 7537001
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2022
• Device Model Number: PL574T
• Device Catalogue Number: PL574T
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/11/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/11/2018
• Type of Device Usage: N
• Patient Sequence Number: 1