MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-12-20 for STERILCONTAINER S BOTTOM STANDARD 90MM JM440 manufactured by Aesculap Ag.
[131925920]
(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 (b)(6) 2017, 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 (b)(6) 2017, thus the feet as the root cause can be excluded. If the feet are older than (b)(6) 2017, the failure would have occurred earlier and could have been prevented by washing it out prior to the first use.
Patient Sequence No: 1, Text Type: N, H10
[131925921]
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 - container bottom standard. Associated medwatches: 9610612-2018-00584 (this report); 9610612-2018-00585; 9610612-2018-00586 ; 9610612-2018-00587.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00584 |
| MDR Report Key | 8187219 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-20 |
| Date of Report | 2019-01-02 |
| Date of Event | 2018-09-16 |
| Date Facility Aware | 2018-12-11 |
| Date Mfgr Received | 2018-12-11 |
| Device Manufacturer Date | 2015-06-01 |
| Date Added to Maude | 2018-12-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERILCONTAINER S BOTTOM STANDARD 90MM |
| Generic Name | STERILIZATION CONTAINERS |
| Product Code | KCT |
| Date Received | 2018-12-20 |
| Returned To Mfg | 2018-12-05 |
| Model Number | JM440 |
| Catalog Number | JM440 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 40 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-20 |