MAUDE Adverse Event Report: AESCULAP AG LIGATURE CLIP 12 MAG.= 144 PCS.; LIGATION / VESSEL CLIPS

Model Number PL572T

Device Problem Unintended Ejection (1234)

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

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 pl572t - ligature clip 12 mag.= 144 pcs.According to the complaint description, it was reported that the clips was ejected into the patient's abdomen.An additional medical intervention was necessary.Additional information was not provided nor available / was not available.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file- no malfunction or serious injury.Investigation results: visual investigation: vigilance investigator carried out the pictorial documentation visually1.A functional test was carried out with an applicator from stock successfully.No deviation could be found.Additionally, the provided cartridges have been forwarded to the responsible q-coordinator of the production plant for further investigations.According to the results to this investigation, the provided cartridges are according to the specifications valid at the time of production, no deviations found.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.Conclusion and measures / preventive measures: according to the investigation report of the q-coordinator, the products provided are according the specifications valid at the time of production.Therefore, a material or manufacturing related error can be excluded.Based upon the investigations results a capa is not necessary.

• Brand Name: LIGATURE CLIP 12 MAG.= 144 PCS.
• 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: 12348683
• MDR Text Key: 267481832
• Report Number: 9610612-2021-00572
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 04038653341856
• UDI-Public: 4038653341856
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/31/2021

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: PL572T
• Device Catalogue Number: PL572T
• Device Lot Number: 52674040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/20/2021
• Supplement Dates Manufacturer Received: 12/10/2021
• Supplement Dates FDA Received: 12/31/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2021
• 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