MAUDE Adverse Event Report: AESCULAP AG LIGATURE CLIP 12 MAG.= 144 PCS.; LAPAROSCOPIC SURGERY

Model Number PL572T

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was an issue with ligature clips.It was reported that during the deployment, the tip of the barrette has broken.There was a foreign body in the patient's body, which is available for investigation.An additional medical intervention was not necessary.There was no surgery delay.The malfunction is filed under aag (b)(4).

Manufacturer Narrative

Investigation : the investigation was performed with following analysis equipment: - digital microscope "keyence vhx-5000" (eq.-nr.: 20000024840); - digital camera dmc-tz61; - fixing compound, object holder, graph paper.The clip cartridge has a broken off nose.The broken off fragment is not available for investigation.The fracture surface has no visible pores, holes.Batch history review: the device history file has been checked for the available lot number and find to be according to our specification valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: the root cause is most likely usage related.Rationale: the fracture surface shows no signs of material fatigue, holes, pores, or any other abnormalities, therefore we can exclude production failures.The fracture was caused most likely from external forces that have overloaded the material.This could happen, when tissue is pressed with too high forces towards the jaw parts joint.The broken off fragment is missing.Corrective action: according to sop sa-de13-m-4-2-04-000-0 (corrective action & preventive action) a capa is not necessary.

• Brand Name: LIGATURE CLIP 12 MAG.= 144 PCS.
• Type of Device: LAPAROSCOPIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9528473
• MDR Text Key: 179469956
• Report Number: 9610612-2019-00865
• 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: 01/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2019
• 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: 52516510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Date Manufacturer Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1