MAUDE Adverse Event Report: AESCULAP AG LIGATING CLIPS M/L 12/BOX; HANDHELD PRODUCTS & LIGATION

Model Number PL569T

Device Problem Unintended Ejection (1234)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that there was an issue with pl569t - ligating clips m/l 12/box.According to the complaint description, the clip charger not functioning - skipping on its own.Patient harm was unknown.Additional information was not provided nor 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.

Manufacturer Narrative

Investigation: the complaint sample was not returned, thus a product investigation was not possible.Review of device history records: the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.The batch-related complaint history review did not reveal any similar complaints for the reported failure mode.Explanation and rationale: due to a lack of information and without the product we cannot determine a root cause for the mentioned deviation.According to the quality standard and the dhr, a production error and a material defect can most probably be excluded.A malfunctioning clip loading / clip charging process can have a variety of reasons, including possible failures in each individual component of the challenger system such as the used handle, the shaft and/or the clip cassette.If further investigations are required, the product should be provided for examination.Conclusion and preventive measures: root cause cannot be finally concluded.Therefore the root cause specific risk cannot be identified.The potential risk determined during initial vigilance evaluation remains valid.Based upon the investigation results, a capa is not necessary.

• Brand Name: LIGATING CLIPS M/L 12/BOX
• Type of Device: HANDHELD PRODUCTS & LIGATION
• 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 gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 16545982
• MDR Text Key: 311745513
• Report Number: 9610612-2023-00051
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K962493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL569T
• Device Catalogue Number: PL569T
• Device Lot Number: 52805699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2022
• 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