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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.
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Manufacturer (Section D)
po box 40
tuttlingen, 78501
GM 78501
Manufacturer (Section G)
po box 40
tuttlingen, 78501
GM 78501
Manufacturer Contact
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
MDR Report Key8187218
MDR Text Key131929887
Report Number9610612-2018-00586
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/07/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberJK742
Device Catalogue NumberJK742
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date12/11/2018
Device Age30 MO
Event Location No Information
Date Manufacturer Received12/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse