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

Model Number PL574T

Device Problems Fracture (1260); Material Fragmentation (1261)

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

Event Date 09/28/2022

Event Type  malfunction  

Event Description

It was reported that there was an issue with pl574t - challenger ti-p sm-ligat.Clips 12 cartr.According to the complainant, after the cartridge was used, it was taken out and the proximal end was found broken.The fragment was suspected to have remained in situ, in the patient's abdomen.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Manufacturer Narrative

Additional information: b5 - event clarification.Investigation results: visual investigation: here we detected a broken off latch, a deformed tip of the slider sheet, and wrong positioned clips.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.There are no similar complaints against the same lot number(s) with this error pattern.The review of risk assessment revealed that the overall risk level (severity 3(5) x probability of occurrence 1(5)) 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 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.Furthermore, according to the ifu, certain points must be observed such as details on inserting and removing the titanium clip cassette.Conclusion and measures / preventive measures: based upon the investigation results, the root cause of the problem is most probably usage-related.Based upon the investigations results a capa is not necessary.

Event Description

Update: the piece was not recovered.The patient had no negative effects.

• Brand Name: CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTR.
• 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: 15579814
• MDR Text Key: 302261085
• Report Number: 9610612-2022-00299
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL574T
• Device Catalogue Number: PL574T
• Device Lot Number: 52700958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• 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