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

Model Number PL569T

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation: the packaging of the ligature clips has been analysed visually by using the pictorial documentation.According to the responsible quality coordinator and manager of the production plant, sterile packages are produced and checked according to quality documents.Therefore, a sealing related error can be excluded.Batch history review: the device quality and manufacturing history records have been checked for all available batch numbers and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: based on the available information as well as the result of the investigation the root cause of the failure is most probably related to an insufficient usage.Rationale: based on the investigation a manufacturing related error can be excluded.It is most likely that an inappropriate opening of the package let to the described failure.Corrective action: capa is not necessary.

Event Description

It was reported that there was an issue with the steril packaging of ligature clips.Three outer packages of the same lot were welded too tightly.The inner packages could not be removed properly because the sterile packaging was torn.The product became unsterile and could not be used.There was no patient harm.Additional information was not provided.The malfunction is filed under aag reference 400437642.

• Brand Name: LIGATING CLIPS M/L 12/BOX
• 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: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8874548
• MDR Text Key: 153714612
• Report Number: 9610612-2019-00536
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K962493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/07/2019

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 Expiration Date: 04/03/2024
• Device Model Number: PL569T
• Device Catalogue Number: PL569T
• Device Lot Number: 52511378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2019
• Initial Date FDA Received: 08/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2019
• 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