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

Model Number PL579T

Device Problem Break (1069)

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

Event Type  Injury  

Event Description

It was reported that there was an issue with pl579t - challenger ti-p ml-ligat.Clips 12 cartr.According to the complaint description, the end of the challenger cartridge snapped off inside the patient during a robotic prostatectomy.They were however able to retrieve it and no harm was done.An additional medical intervention was necessary.Additional information was not provided.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

Additional information: h6 - codes updated.Investigation: an investigation method could not be applied, because products were not provided to us for investigation.In the picture provided in sap, the nose of the product is fractured.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.Explanation, rationale, conclusion and root cause: unfortunately, without the product, and only with the picture archived in sap database, we cannot determine the exact cause.According to the quality standard, a material defect and a production error can most probably be excluded.If further investigations are required, the product should be provided for examination.A capa was already initiated for various failure modes of the challenger system.

• Brand Name: CHALLENGER TI-P ML-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: 16134023
• MDR Text Key: 307039209
• Report Number: 9610612-2022-00397
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K081031
• 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: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL579T
• Device Catalogue Number: PL579T
• Device Lot Number: 52797612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2022
• Initial Date FDA Received: 01/10/2023
• Supplement Dates Manufacturer Received: 02/06/2023
• Supplement Dates FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male