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

Model Number PL579T

Device Problem Unintended Ejection (1234)

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

Event Date 04/07/2022

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, during a surgical procedure, after a first series of clip which went well, the second charger fell in the belly, after several poses of clip, the installation of another charger led to the same result.An additional medical intervention was necessary.Additional information was not provided nor available.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).Involved components: pl520r - challenger ti-p handle - lot unknown.

Event Description

Associated medwatch reports: 400552102 (9610612-2022-00115) pl579t -- challenger ti-p ml-ligat.Clips 12 cartr.Involved components: pl520r - challenger ti-p handle - lot unknown (400552979).Pl536r - shaft compl.D:10mm l:370mm - lot unknown (400551734).The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Additional information: b5 and d10 updated - associated medwatch reports and involved components clarified.Investigation: visual inspection: we detected a broken off piece of the lateral webs.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.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 3(5) x probability of occurrence 1(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: there are no hints of a pre-damage or something similar.Investigations lead to the assumption that the cartridge was engaged not completely or was damaged during insertion.If either of these occurr, there is an impairment of product functionality.This can cause the cartridge to jump off.Based upon product experience and due to different simulations involving a cartridge which is not completely engaged, this has led to the described errors.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 required.

• 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: 14224809
• MDR Text Key: 290287320
• Report Number: 9610612-2022-00115
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 06/07/2022

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: PL579T
• Device Catalogue Number: PL579T
• Device Lot Number: 52730723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2022
• Initial Date FDA Received: 04/27/2022
• Supplement Dates Manufacturer Received: 05/23/2022
• Supplement Dates FDA Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PL520R - CHALLENGER TI-P HANDLE; PL520R - LOT UNKNOWN; PL536R - SHAFT COMPL.D:10MM L:370MM -
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male