MAUDE Adverse Event Report: AESCULAP AG LIGATURE CLIP 12 MAG.= 144 PCS.; HANDHELD PRODUCTS & LIGATION

Model Number PL572T

Device Problem Fracture (1260)

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

Event Date 08/31/2022

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 tab was broken and recovered.After successfully implanting the first clip using a challenger forceps, a pin became dislodged and fell into the patient.The pin was successfully recovered and the operator then noticed that the tab allowing its adhesion to the clamp was broken.This occurred during a robot-assisted total nephro-uretectomy.The malfunction also occurred a second time with a product having the same batch; the third product functioned and the operation was completed.An additional medical intervention was necessary.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).

Event Description

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

Manufacturer Narrative

Update: h6-codes.Visual investigation: the used product was not available for investigation.We received a unused, sealed sample form the same batch.After the visual inspection of the product, there was no visible deviation.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.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability 1(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 errorcan be excluded.There are no hints of a pre- damage or something similar.Investigation leads to the assumption that the cause for the mentioned deviation was caused by a improper removal of the titanium clip cartridge from the challenger shaft.If the magazine was removed not according to the instructions for use (ifu), there is the possibility that the latch broke off.In addition, a rough removal of the magazine from the sterile packaging could also lead to a broken off latch.Furthermore, the deformed tip of the slider sheet was most likely caused by the jaws being closed while the slider sheet was still in the jaws to forward a clip.Conclusion and measures / preventive measures: based upon the investigation results the root cause is most probably usage-related.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

• Brand Name: LIGATURE CLIP 12 MAG.= 144 PCS.
• Type of Device: HANDHELD PRODUCTS & LIGATION
• 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: 15626242
• MDR Text Key: 301934815
• Report Number: 9610612-2022-00304
• Device Sequence Number: 1
• Product Code: FZP
• 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: 12/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• 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: 52675218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2021
• 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