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

Model Number PL574T

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: the product is available in a sterile, unopened condition.According to the available information, there were no negative consequences for the patient or any other persons.Investigation: the complete blister-in-blister package is bagged respectively inflated.The investigation was performed with following analysis equipment: digital microscope "keyence vhx-5000" (eq.-nr.: (b)(4)), digital camera dmc-tz61, coffee-cup with drinking water for leakage test of the gas cylinder, fixing compound, object holder, graph paper.The inner blister packaging has two volumes separated through a divider sealing seam: one volume contains a carbon dioxide cylinder and the another one a the clip cartridge.The outer blister has only one volume and contains the inner blister.It's a so-called blister-in-blister sterile packaging.The sealing seam of the outer-blister and the transparent cavity-part are showing no abnormalities.The white sealing foil has an approx.33mm long cut below the imprinted label.The cutting edges point to a very sharp cutting tool, like a scalpel or a cutter knife, because there could not be detected any deformations or frays at the foil edges.On both pull tabs of the outer blister is a manually written note.The on-printed label on the white sealing foil is partially blurred.The complete double-blister is bagged respectively inflated.The transparent cavity part and the sealing seam of the outer blister shows no abnormalities.The barrier between both volumes of the inner-blister is broken.The cavity of the gas cylinder is mashed.The divider sealing seam between the both inner-blister cavities is completely peeled off.The circulating sealing seam of the inner-blister is unopened.Near the pull-tabs the sealing seam is nearly broken from inside out.The inner-blister is in its unopened condition is inflated.The gas cylinder shows at the visual inspection no visible abnormalities on its surface.At the underwater leakage test the gas cylinder shows a very small micro-leakage at the spot of the bigger bubble which appears permanently an very slow at the same place of the welding seam of the piercing membrane.Batch history review: the device quality and manufacturing history records have been checked for lot number 52531433 and found to be according to our specification valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: the root cause is most probably usage related.Rationale: the cut in the sealing foil of the outer-blister was not caused by an fast gas expansion like an explosion, because the foil has no traces of tensile stress and the sealing seam is closed.The mashed gas cylinder cavity of the inner-blister was not caused by an over-pressure event in the blister cavity.The deformation-traces are a result of a mechanical overload stress from outside of the double-blister.The outer-blister was only deformed in his elastic area and the deformation disappeared after compressive stress has stopped.The inner-blister was deformed too but in the plastic area.That's why the inner-blister kept his deformation traces.If there has been an event like a sudden gas expansion, both blister would have an hole an inflation would be impossible.If the storage temperature is over the recommended storage temperature of 50°c like mentioned in the owners manual a gas leakage will be a result.In a very rare cases a leakage with a very small flowrate is possible.Under these circumstances the blister becomes inflated without a visible hole and stays inflated over a long time until the gas cylinder becomes empty.Corrective action according to (b)(4) (corrective action & preventive action) a capa is not necessary.

Event Description

It was reported that there was an issue with challenger ti-p ligat.Clips.There was a problem related to the packaging.It was reported that the blister which contains the gas cartridge and the clips were completely rounded as if the cartridge had exploded inside.There was no patient harm.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).

• Brand Name: CHALLENGER TI-P SM-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: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9255551
• MDR Text Key: 179125620
• Report Number: 9610612-2019-00745
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL574T
• Device Catalogue Number: PL574T
• Device Lot Number: 52531433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2019
• 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