MAUDE Adverse Event Report: AESCULAP AG AESCULAP; CLIP, SCALP

Model Number FF013P

Patient Problem Foreign Body In Patient (2687)

Event Date 10/16/2023

Event Type  malfunction  

Event Description

Surgical team reported an unintentionally retained raney clip following a craniectomy despite correct clip count.Unable to count the raney clips before use because the applicator is pre-loaded by the manufacturer.The pre-loaded cartridge is grayed out, which does not allow for full visualization of all of the raney clips in the cartridge before being used.Unable to visualize the raney clip that was retained on post-operative imaging because the clips are not radiopaque.Patient required an additional procedure to remove the retained raney clip.

• Brand Name: AESCULAP
• Type of Device: CLIP, SCALP
• Manufacturer (Section D): AESCULAP AG; 3773 corporate pkwy; center valley PA 18034
• MDR Report Key: 18621475
• MDR Text Key: 334309031
• Report Number: 18621475
• Device Sequence Number: 1
• Product Code: HBO
• 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: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF013P
• Device Catalogue Number: FF013P
• Device Lot Number: 52829569
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/09/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6935 DA
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Hispanic