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

Model Number PL579T

Device Problem Material Fragmentation (1261)

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

Event Date 07/28/2022

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 pl579t - challenger ti-p ml-ligat.Clips 12 cartr.According to the complaint description, the plastic tip broke.The tip fell into the patient's abdomen and the metal foil detached.An additional medical intervention was required.Revision and recovery of the broken parts was performed.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch reports: 400565143 (9610612-2022-00254) pl569t.

Event Description

Associated medwatch-reports: (b)(4) (9610612-2022-00252) pl579t.(b)(4) (9610612-2022-00254) pl569t.

Manufacturer Narrative

Additional information: d9- product return date.Investigation results: visual investigation: we made a visual inspection of the products, here we detected a broken off nose and a detached slider sheet.In addition, there is no clip left in the titanium clip cartridge.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification 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 4(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 cause by an improper handling.If the titanium clip cartridge were removed not according to the instruction for use (ifu) from the challenger shaft, there is the possibility that the slider sheet detaches from the titanium clip cartridge housing, or the nose broke off.Additionally, the broken off nose was most probably caused by exerting too much force to the nose during application.If the surgeon pushes the nose of the cartridge into the tissue it can be the possibility that the nose broke off and the slider sheet deforms.Possibly a damaged clip applicator due to a deformed push rod or something similar could be another cause.Furthermore, according to the ifu the following points must be observed: removing the titanium clip cassette -> close the jaws with the application lever and withdraw the titanium clip cassette.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 investigation results, a capa is not necessary.

• Brand Name: CHALLENGER TI-P ML-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: 15242988
• MDR Text Key: 298075496
• Report Number: 9610612-2022-00252
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL579T
• Device Catalogue Number: PL579T
• Device Lot Number: 52765402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2022
• 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
• Patient Age: 39 YR