MAUDE Adverse Event Report: AESCULAP AG CHALLENGER TI-P HANDLE CARTR.; LAPAROSCOPIC SURGERY

Model Number PL520R

Device Problems Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/26/2019

Event Type  malfunction  

Manufacturer Narrative

Associated medwatch-reports: 9610612-2019-00691 (400444658 - pl520r), 9610612-2019-00692 (400444661 - pl574t), 9610612-2019-00693 (400444660 - pl574t), 9610612-2019-00694 (400444659 - pl522r).Investigation: the instrument and cartridges arrived in a decontaminated condition and they are available for investigation.Failure description: the instrument arrived in a clean status without visible damage.The cartridges arrived in a clean status with visible damaged lateral webs and one of them with a deformed slider sheet.The investigation was carried out visually and microscopically with the digital microscope and the digital-camera.We made a visual inspection of the shaft pl522r.Here we found scratches.Additionally we made an optical inspection of the co 2 cylinder ta012286.We detected unknown deposits.Furthermore we made a visual inspection of the handle pl520r.No visible failure could be discovered.The shaft pl522r and handle pl520r shows the following service date: 2020-07.We made a functional test with two unused cartridges pl574t and no failure could be found.We also made an optical inspection of the two complained cartridges.One cartridge shows a visible damages slider sheet.We also detected wrong positioned clips but no deformed latches or deformed nose of the slider sheet could be discovered.We found a visible damaged lateral web.The second cartridge shows also wrong positioned clips and no deformed latches or deformed nose of the slider sheet could be found.We also detected a visible damaged lateral web.A clip jam could not be discovered.Furthermore the instrument was send to the production department for further investigation.Regarding the analysis report: "on the production side, no faults can be detected." batch history review: the device quality and manufacturing history records have been checked for all the lot numbers (62311788 / 62314702 / 52429778) and found to be according to the specification, valid at the time of production.No similar incidents have been filed with products from these batches.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.The functional test shows no product related error regarding the instrument.Investigations lead to the assumption that the wrong positioned clips were caused by an improper handling.We simulated a too fast application with the instrument and new unused cartridges.This leads to wrong positioned clips and to a deformed slider sheet.Additionally the too fast application led to a jumped off cartridge.The visible damaged lateral webs could have caused due the jumping off.There is the possibility for an assembly error and therefore the cartridge could came off when trying to approach to intrathoracic through trocar.We cannot determine during the functional test that the working end could not be detached.Additionally according to the investigation report of the quality assurance of the production department: "specification: pl522r: magazine retention force at least 2.0 n.Check handle according to test plan pl520875: handle: tightness test.Put numbered dummies in the rotating star.Pierce cartridge.Uncoupling the shaft.Weigh handle with precision scale to mg accuracy.Note the measured value in the form.60 min.Service life with pierced cartridge at test temperature according to drawing.Weigh handle with precision scale to mg accuracy.Note the measured value in the form.Determine weight loss and archive for order: max.Permissible weight loss.Cycle test: test shaft: couple pl538860 (ø=10mm; l=260mm) with magazine on handle.4 clips.Then remove the magazine from the shaft.Count the number of operations until there is no more feed movement.(minimum number of cycles see drawing).Current state: shaft pl522r: complies with specification, magazine holding force 2.4 n handle pl520r: complies with specification.Cause: the shaft pl522r was closed before the slide plate of the magazine was in end position.On the production side, no faults can be detected." corrective action: according to sa-de13-m-4-2-04-000-0 (corrective action & preventive action) there is no capa necessary.

Manufacturer Narrative

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

Event Description

It was reported that there was an issue with product pl520r - challenger ti-p handle cartr.It was reported that " the products were used for the blood vessels around esophageal surgery recurrent nerve.After using a few clips, the working end could not be detached from patient's tissue.After that clips got jammed and could not be used any more.The surgeon moved the jaw carefully and detached it finally." the malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2019-00692 ((b)(4) - pl574t), 9610612-2019-00693 ((b)(4) - pl574t), 9610612-2019-00694 ((b)(4) - pl522r).Involved components: pl574t - challenger ti-p sm-ligat.Clips 12 cartr.- 52429778, pl574t - challenger ti-p sm-ligat.Clips 12 cartr.- 52429778, pl522r - shaft compl.D:5mm l:310mm.

• Brand Name: CHALLENGER TI-P HANDLE CARTR.
• Type of Device: LAPAROSCOPIC SURGERY
• 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: 9147003
• MDR Text Key: 170561201
• Report Number: 9610612-2019-00695
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K081031
• 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,Followup
• Report Date: 12/12/2019

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 Model Number: PL520R
• Device Catalogue Number: PL520R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2019
• Initial Date FDA Received: 10/02/2019
• Supplement Dates Manufacturer Received: 11/21/2019
• Supplement Dates FDA Received: 12/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1