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

Model Number PL572T

Device Problem Failure to Eject (4010)

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

Event Date 07/14/2022

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, the cartridge came off.This occurred during an unspecified esophageal procedure.A non-aesculap clip was used instead to complete the surgery.It was noted that upon the second shot, it was not loaded; it then fell into the patient's body.It was "caught" in the abdominal wall; the next day, it was found and recovered.An additional medical intervention was required.Additional information was not provided.The adverse event is filed under aag reference (b)(4).

Event Description

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

Manufacturer Narrative

Investigation results: visual: we made a visual inspection of the complaint sample, and here we detected mispositioned clips on the slider sheet.The clips were no longer located betweeen the latches and the nose of the slider sheet.Mispositioned clips can be considered the preliminary stage of a clip jam.Furthermore, one latch on the tip of the slider sheet was found to be deformed.The failure mode resulting from this case has been evaluated already in another cc (notification 400577001) and can therefore be defined as a repeating error.The repeating failure mode was confirmed based on visual examination of the complaint sample.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.The batch-related complaint history review did not reveal any similar complaints for the reported failure mode.The review of risk assessment revealed that the overall risk level (severity 3(5) x probability 2(5) of occurrence) according to din en iso 14971 is still acceptable.Explanation and rationale: according to the quality standard and dhr files a material defect and a production error can be excluded.There are no hints of a pre-damage or similar.Investigation leads to the assumption that the cause for the mentioned deviation was caused by an improper handling.If the clip cassette is not engaged completely to the shaft or if it is damaged during handling, an impairment of product functionality occurs.In consequence, this could lead to mispositioned clips and ultimately to a clip mam.Further, it is possible that a mispositioned clip occurs, if the clip application is performed with excessive speed.Conclusion and measures / preventive measures: based upon the investigation results, the root cause is most probably usage-related.Product safety cases had been initiaited.A capa had been opened previously to further evaluate root cause.

• 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: 15175386
• MDR Text Key: 297338270
• Report Number: 9610612-2022-00194
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K081031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• 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: 52752029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2022
• 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