MAUDE Adverse Event Report: AESCULAP AG LIGATURE CLIP 12 MAG.= 144 PCS.; LIGATION / VESSEL CLIPS

Model Number PL572T

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: the cartridge arrived in a decontaminated condition and it is available for investigation.The broken off part is missing.Investigation: the investigation was carried out visually and microscopically with the digital microscope vhx-5000 keyence (eq.-nr.(b)(4)) and the digital-camera "panasonic dmc tz8".We made a visual inspection of the cartridge.Here we found wrong positioned clips.Additionally we detected a broken off latch.The broken off surface shows no anomalies.We do not discovered deformed latches or deformed nose of the slider sheet but we found a deformed slider sheet.Batch history review: the device quality and manufacturing history records have been checked for the lot number (52442279) 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 52442279.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.No pores or foreign bodies could be found on the point of rupture.Investigations lead to the assumption that the wrong positioned clips were caused by an improper handling.It appears that a too fast application leads to the wrong positioned clips and to the deformed slider sheet.Based upon our historically grown product experience and due to different simulation regarding a too fast application, this leads to the described errors.The broken off latch could have caused due to a handling related error.This could cause by an improper removal out of the primary sterile package or improper inserting of the cartridge.If the cartridge is engaged not completely or was damaged during inserting, there is an impairment of product functionality.This could also led to the described errors.Corrective action: according to (b)(4) (corrective action & preventive action) there is no capa necessary.

Event Description

It was reported that there was an issue with a ligature clip.During a surgery the second clip magazine was jammed from second shot.Due to jamming of the clips in the magazine, the clip was not loaded into the jaws.The surgeon was not aware of it and consequently, the surgeon grasped a vein with jaws that was not loaded with a clip.The surgery was finished without any problems and the patient was safe too.The first clip magazine and the third clip magazine was used without problems.There was no patient harm.The malfunction is filed under aag reference (b)(4).

• Brand Name: LIGATURE CLIP 12 MAG.= 144 PCS.
• 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: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9372572
• MDR Text Key: 179251904
• Report Number: 9610612-2019-00776
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: JM
• PMA/PMN Number: K962493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: PL572T
• Device Catalogue Number: PL572T
• Device Lot Number: 52442279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 11/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2018
• 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