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

Model Number PL569T

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 pl569t - ligating clips m/l 12/box.According to the complaint description, the clip cartridge and clips fell in situ during surgery.Type of surgery: laparoscopic gall bladder.No single clips remained in the patient.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).Concomitant medical products: pl510r - handle f/pl506r & pl508r - lot unknown, pl536r - shaft compl.D:10mm l:370mm - lot unknown.

Manufacturer Narrative

Investigation results: visual investigation: the examination was carried out visually and microscopically.No deviations were found during the visual inspection.Furthermore, the products were sent to the quality assurance department of the production department for further analysis.They were unable to determine a cause as there was no production defect.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.Based upon the investigations results a capa is not necessary.

Event Description

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

• 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
• MDR Report Key: 11029264
• MDR Text Key: 226059712
• Report Number: 9610612-2020-00936
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K962493
• 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: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL569T
• Device Catalogue Number: PL569T
• Device Lot Number: 52635503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PL510R - LOT UNKNOWN; PL536R - LOT UNKNOWN
• Patient Outcome(s): Required Intervention