MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-01-03 for BOTTOM FOR 1/2 CONTAINER HEIGHT:120MM JK341 manufactured by Aesculap Ag.
[96456211]
(b)(4). Manufacturing site evaluation: evaluation on-going. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[96456212]
Country of complaint: usa. After the sterilization process was completed, a black debris was noticed in the bottom of the container. This has happened in several sets and we are trying to determine where the debris is coming from and what it is specifically. No injury to patient. No delay in surgery, but there were cancellation of surgery. Components in use listed as concomitant devices are: jk341 / bottom for 1/2 container height:120 mm. Jk389 / 1/2-size lid w/retention plate silver. Jf114r / 1/2 size perf basket 243 x 253 x 106 mm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00004 |
| MDR Report Key | 7162299 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-01-03 |
| Date of Report | 2018-08-20 |
| Date of Event | 2017-12-13 |
| Date Facility Aware | 2018-01-02 |
| Date Mfgr Received | 2018-01-16 |
| Date Added to Maude | 2018-01-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | BOTTOM FOR 1/2 CONTAINER HEIGHT:120MM |
| Generic Name | CONTAINER BOTTOMS 1/1, 1/2, 3/4, EN |
| Product Code | FRG |
| Date Received | 2018-01-03 |
| Model Number | JK341 |
| Catalog Number | JK341 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-01-03 |