MAUDE Adverse Event Report: AESCULAP AG CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTR.; LAPAROSCOPIC SURGERY

Model Number PL574T

Device Problem Compatibility Problem (2960)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation on-going.Additional information and results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with challenger ti-p sm-ligat.Clips.It was reported that there was an shooting error.The customer describes that by pressing one button three clips have been occurred.That was applied in a uro prostatectomy operation.They used hemozip for alternative.There was no patient harm.Additional information was not provided.The adverse malfunction is filed under aag (b)(4).

Manufacturer Narrative

Due to the clarification during review of the investigation results, the report was reassessed and found to no longer require submission - no mulfunction or serious injury.Investigation: the cartridges arrived in a clean status with clip jams and bent latches of the metal sheet.During internally decontamination according to iso 12891-1, the cartridges were deformed.The investigation was carried out visually and microscopically with the digital microscope and the digital-camera.We made a visual inspection of the two cartridges.One have eight clips and the other cartridge have three clips.We also found wrong positioned clips and deformed cartridges.Furthermore we detected deformed latches of the slider sheet.The second slider sheet shows no wrong positioned clips and no deformed latches.Batch history review the device quality and manufacturing history records have been checked for the lot number (52514087) and found to be according to the specification, valid at the time of production.One similar incident have been filed with a product from the batch 52514087 (cc (b)(4)).Conclusion and root cause the root cause of the problem is most probably usage related.Rationale according to the quality standard and dhr files a material defect and production error can be excluded.Investigations lead to the assumption that the wrong positioned clips were caused by an improper handling.It appears that the latches of the slider sheet were deformed by a too fast application.A too fast application leads also to the wrong positioned clips.Possibly a damaged clip applicator due to a deformed push rod or something similar could be another cause for the wrong positioned clips.There is the possibility that the deformation of the cartridge caused during reprocessing for the investigation.Corrective action according to sa-de13-m-4-2-04-000-0 (corrective action & preventive action) there is no capa necessary.

• Brand Name: CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTR.
• Type of Device: LAPAROSCOPIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9135305
• MDR Text Key: 160693615
• Report Number: 9610612-2019-00672
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K081031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2024
• Device Model Number: PL574T
• Device Catalogue Number: PL574T
• Device Lot Number: 52514087
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1