MAUDE Adverse Event Report: AESCULAP AG BOTTOM FOR 3/4 CONTAINER HEIGHT:135MM; STERILIZATION CONTAINERS

Model Number JK742

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: failure description - several scratches can be found on the surface of all container components, most likely caused by wear and tear.In addition, one container bottom and lid was discolored in brown/black.No deviation was found on the retention place and the filter.The provided particles are glued onto a sheet of paper with adhesive tape.Investigation - investigation carried out on the pictorial documentation visually and microscopically.In similar complaints, the detected brown/black discoloration was tested and had a negative result with fluoric acid on the product surface.This layer (elevated chrome content) through our results can only be removed mechanically, not by any basic cleaner or other chemical.In most cases these layers are created by a chemical reaction of the product with the product surface with phosphor-containing liquids, such as neutralizer base in phosphoric acids in machine cleaning processes.Dosage errors or insufficient rinsing may be the cause.Such discoloration does not reduce the lifetime of the product nor does it represent a hygienic risk.A material or manufacturing issue was not detected.According to the ifu, sterile container s can use hydrogen peroxide for sterilization.Certain fragments are most likely fragments of container feet.The breakage of these fragments was most likely caused by extensive force, since the analysis of the fracture pattern illustrated a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the point of rupture.Other fragments are small and black whose origin is yet unknown.In the container system there are 2 components made of black material, the feet of the basket and the mechanism of the retention plate.Nevertheless, the black fragment could also originate from a device or similar products during reprocessing.There was one grey, shiny fragment which was most probably from another device or instrument.In 2016, a similar issue with black flakes in sterile containers occurred, caused by a worn injection-molding tool.In this case, a "vendor related defect" notification was created and corrective action was taken.There was rework of the tool with an optimized design of the foot.Since 27mar2017, no more products were produced according to the old production standards.According to the ifu, new sterile containers must be cleaned prior to the first use, to wash out foreign objects.Since the basket and hence the feet were not available, we cannot determine a final root cause of this failure.No missing parts or deviations can be found on the provided retention plate.Conclusion and root cause- based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage.Rationale - the basket and feet were not available, nor the date of production.Nevertheless, there are new feet available since march 2017, thus the feet as the root cause can be excluded.If the feet are older than march 2017, the failure would have occurred earlier and could have been prevented by washing it out prior to the first use.

Event Description

It was reported that metal shavings and black/grey residue were found in the bottom of an instrument container.The issue was noted in the operating room but prior to use of the contents in the sterile field.There was a 10-minute delay in surgery but there was no patient harm or intervention required.The case was a urology procedure.It was felt that the repetition of placing lids on and off the bottom may be causing this malfunction.This case represents the component - bottom for 3/4 container.Associated medwatches: 9610612-2018-00584, 9610612-2018-00585, 9610612-2018-00586 (this report), 9610612-2018-00587.

Manufacturer Narrative

The scratches on all the mentioned containers components are most likely caused by wear and tear.In similar complaints, the detected brown/black discoloration was tested by a negative result of a fluoric acid test as a corrosion resistant chrome oxide passivation layer on the product surface.This layer (elevated chrome content) can by our current experience only be removed mechanically, not by any basic cleaner or other chemistry.In most cases these layers are created by a chemical reaction of the product surfaces with phosphor-containing liquid, such as neutralizers' base on phosphoric acids in machine cleaning processes.Dosage errors or insufficient rinsing may be the causes.Such black discoloration do not reduce the lifetime of the product, nor do they represent a hygienic risk they can be regarded a pure aesthetic tissue.A material or manufacturing issue was not detected.The breakage of these fragments was most likely caused by extensive force, since the analysis of the fracture pattern illustrated a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the point of rupture.In the container system are two components made of black materials, of the feet of the basket and the mechanism of the retention plate.Nevertheless, the black fragment could also originate from a device or similar products during reprocessing.In 2016 a similar issue with black flakes in sterile containers already occurred, caused by worn injection-molding tool in this case, a "vendor related defected" notification was created.A short term corrective action was to intensify the inspection of the goods as well as a rework of our incoming inspection.Additionally the staff was trained on the 17th of february 2016.Midterm action: rework of the injection-molding tool.As a long term action a new injection molding tool, with an optimized design of the foot, was created.Since the basket and hence the feet is not available, we cannot determine a final root causes of this failure.No missing parts or deviations can be found on the provided retention plate.Based on the information available as well as a result of our investigation the root causes of the failure is most probably related to an insufficient usage.Since the feet of the basket are not available for investigation, we cannot determine a production date of the feet.Nevertheless, there are new feet available since march 2017, thus the feet as the root causes can be excluded.If the feet are older than march 2017 the failure should have been occurred earlier and could have been prevented by washing it out prior the first use.A capa is not necessary.

• Brand Name: BOTTOM FOR 3/4 CONTAINER HEIGHT:135MM
• Type of Device: STERILIZATION CONTAINERS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8187218
• MDR Text Key: 131929887
• Report Number: 9610612-2018-00586
• Device Sequence Number: 1
• Product Code: FRG
• Combination Product (y/n): N
• PMA/PMN Number: K792558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JK742
• Device Catalogue Number: JK742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Distributor Facility Aware Date: 12/11/2018
• Device Age: 30 MO
• Date Manufacturer Received: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FILTER POLYPROPYLEN RUND; FILTER RETENTION PLATE; INSTRUMENT BASKET