MAUDE Adverse Event Report: AESCULAP AG CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTR.; LIGATION / VESSEL CLIPS

Model Number PL574T

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 09/04/2023

Event Type  malfunction  

Event Description

It was reported that there was an issue with the product pl574t - challenger ti-p sm-ligat.Clips 12 cartr.According to the complaint description, the cartridge detached intraoperatively.Aditionally, when the packaging was opened, the tip was found broken and could not be set.Patient harm was unknown.Additional information was not provided nor available.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

• Brand Name: CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTR.
• Type of Device: LIGATION / VESSEL CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 17847130
• MDR Text Key: 324630246
• Report Number: 9610612-2023-00215
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K081031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• 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: 52836176
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1