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 2016-10-14 for FULL-SIZE LID W/RETENTION PLATE SILVER JK489 manufactured by Aesculap Ag.
[57438260]
(b)(4). Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[57438261]
Country of complaint: (b)(6). It was reported that while preparing for a total knee arthroplasty surgery, when opening the cover to use instruments the filter with the holder dropped inside the container. There was a two hour delay in surgery in order to complete a sterilization on the instruments. The procedure was completed without any harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2016-00848 |
| MDR Report Key | 6029699 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-10-14 |
| Date of Report | 2017-10-30 |
| Date of Event | 2016-09-14 |
| Date Facility Aware | 2016-09-30 |
| Date Mfgr Received | 2016-09-15 |
| Date Added to Maude | 2016-10-14 |
| 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 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 | FULL-SIZE LID W/RETENTION PLATE SILVER |
| Generic Name | STERILE TECHNOLOGY |
| Product Code | FRG |
| Date Received | 2016-10-14 |
| Returned To Mfg | 2016-09-23 |
| Model Number | JK489 |
| Catalog Number | JK489 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2016-10-14 |