MAUDE Adverse Event Report: AESCULAP AG CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTR.; LAPAROSCOPIC SURGERY

Model Number PL574T

Device Problem Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was an issue with challenger ti-p sm-ligat.Clips.It was reported that the cartridge fell into the thoracic cavity from the applier.The staff changed the cartridge and it fell out again.The cartridge was retrieved and the patient was safe.There was no patient harm.Additional information was not provided.The malfunction filed under aag (b)(4).Associated medwatch-reports: 9610612-2019-00735 ((b)(4) pl522r), 9610612-2019-00736 ((b)(4) pl520r).

Manufacturer Narrative

Manufacturing site evaluation: we received a complaint about an intraoperatively malfunction of a challenger applicator.According to the available information, there were no negative consequences for the patient.Batch history review: the device quality and manufacturing history records have been checked for the available lot number 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: without the product, an exact cause cannot be determined at this moment.Based on the quality standard and the device history records, a material or production related error can be excluded.Therefore, the root cause of the error is most probably usage related.Rationale: according to the quality standard, a material defect and production error can be excluded.A usage related error cannot be excluded, e.G.Due to improper handling or an overload situation.Corrective action: a corrective action and preventive action is not necessary.

Event Description

Associated medwatch reports: 9610612-2019-00736 ((b)(4), pl520r) and 9610612-2019-00735 ((b)(4), pl522r).

• Brand Name: CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTR.
• Type of Device: LAPAROSCOPIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9240910
• MDR Text Key: 177368682
• Report Number: 9610612-2019-00737
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K081031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• 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
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1