MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-02-05 for FULL-SIZE LID W/RETENTION PLATE SILVER JK489 manufactured by Aesculap Ag.
[99093734]
(b)(4). Manufacturing site evaluation: the device arrived in a decontaminated condition and available for investigation. Lid 1 with 2 retention plates: a visual inspection of the full-size lid with retention plate silver jk489. Here was found visible damage of a deformed cover. Furthermore a visual inspection of the filter retention plates jk100. Both retention plates had visible damage at the internal seal. Both locking bolts show no visible damage. Lid 2 with 2 retention plates: next a visual inspection of the full-size lid with retention plate silver jk4879. Here it was found visible damage. Furthermore a visual inspection of the filter retention plate jk100. A deformation and gaps were found between the retention plate and external seal. Additional a visible damage at the internal seal. The locking bolt shows no visible damage. The product does not require batch management; a review of the device quality and manufacturing history records is not possible. The root cause of the problem is most probably usage related. A capa is not necessary.
Patient Sequence No: 1, Text Type: N, H10
[99093735]
(b)(6). Components in use listed as concomitant deviecs are: jk489 / full-size lid w/retention plate silver (2); jk100 / filter retention plate (2).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00041 |
| MDR Report Key | 7242470 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-02-05 |
| Date of Report | 2018-02-05 |
| Date Facility Aware | 2018-01-18 |
| Date Mfgr Received | 2016-04-07 |
| Date Added to Maude | 2018-02-05 |
| 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 |
| 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 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 | FULL-SIZE LID W/RETENTION PLATE SILVER |
| Generic Name | STERILE TECHNOLOGY |
| Product Code | FRG |
| Date Received | 2018-02-05 |
| Returned To Mfg | 2016-04-04 |
| Model Number | JK489 |
| Catalog Number | JK489 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 1. Other | 2018-02-05 |