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

Model Number PL579T

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/26/2020

Event Type  Injury  

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 pl579t - challenger ti-p ml-ligat.Clips 12 cartr.According to the complaint description, the cartridge fell in situ during surgery.Type of surgery: robot-assisted radical prostatectomy, all pieces have been recovered.An additional medical intervention was necessary.Additional information was not provided nor available.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).Involved components: pl536r - shaft compl.D:10mm l:370mm - lot: 62304844, pl520r - challenger ti-p handle - lot: unknown, pl536810 - jaw part protection for challeneger d 5 - lot: unknown.

Manufacturer Narrative

Investigation results: visual investigation: visually, the provided devices are in a used condition.The applier has been forwarded to the responsible q-coordinator of the production plant.It was found that the recommended maintenance date has been exceeded.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material, manufacturing- or design-related failure.

Event Description

The adverse event is filed under aag reference: (b)(4).

• 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
• MDR Report Key: 11066010
• MDR Text Key: 223430602
• Report Number: 9610612-2020-00961
• 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: 04/07/2021

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: 52625554
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 03/16/2021
• Supplement Dates FDA Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PL520R.; PL536810.; PL536R.; PL520R; PL536810; PL536R
• Patient Outcome(s): Required Intervention