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 2019-04-24 for AESCULAP SURGICAL INSTRUMENTS JK489 manufactured by Aesculap Ag.
[143036218]
(b)(4). If additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[143036219]
It was reported the lids were warped causing sterility concerns. The reporter indicated that upon preparation of the or for an enduro hinge total knee revision (tkr) case, it was discovered that 4 out of the 10 sterile containers for the enduro instrument sets had lids that were warped (likely from shipping). The containers did not seem to be holding a tight vacuum seal around filter. Due to sterility concerns, the case was cancelled and rescheduled for the follow day (b)(6) 2019. The patient was not yet under anesthesia, however, due to the cancellation of the procedure, the patient required an extra day/night in the hospital. The surgery did occur the following day as planned. No patient information has been provided. Additional information has been requested, however, not yet received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2019-00013 |
| MDR Report Key | 8545445 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-24 |
| Date of Report | 2019-04-24 |
| Date of Event | 2019-03-26 |
| Date Facility Aware | 2019-03-28 |
| Date Mfgr Received | 2019-03-26 |
| Date Added to Maude | 2019-04-24 |
| 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 USA |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AESCULAP SURGICAL INSTRUMENTS |
| Generic Name | GENERAL SURGICAL INSTRUMENTS |
| Product Code | FRG |
| Date Received | 2019-04-24 |
| Model Number | JK489 |
| Catalog Number | JK489 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Hospitalization | 2019-04-24 |