MAUDE Adverse Event Report: AESCULAP AG LIGATURE CLIP 12 MAG.= 144 PCS.; LIGATION / VESSEL CLIPS

Model Number PL572T

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2022

Event Type  malfunction  

Event Description

It was reported that there was an issue with pl572t -ligature clip 12 mag.= 144 pcs.According to the complaint description, the clip jammed intraoperatively.Patient harm was unknown.Further details have been requested.The adverse event 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 results: there was no complaint sample provided for investigation, therefore an investigation could not be performed.Batch history review: 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 revealed two similar complaint/s for the reported failure mode.Explanation and rationale: due to a lack of data and without the product we cannot determine an exact conclusion and root cause for the mentioned deviation.According to the quality standard, a production error and a material defect can most probably be excluded.If further investigations are required, the product should be provided for examination.Conclusion and measures / preventive measures: based upon the investigation resulsts, 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 investigations results a capa is not necessary.

Event Description

The malfunction is filed under aag reference (b)(4).

• Brand Name: LIGATURE CLIP 12 MAG.= 144 PCS.
• 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: 15996605
• MDR Text Key: 308236724
• Report Number: 9610612-2022-00362
• 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,Followup
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL572T
• Device Catalogue Number: PL572T
• Device Lot Number: 52747320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/24/2022
• 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