MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-06-29 for 1/2-SIZE LID W/RETENTION PLATE SILVER JK389 manufactured by Aesculap Ag.
[112844713]
(b)(4). Manufacturing site evaluation: evaluation on-going
Patient Sequence No: 1, Text Type: N, H10
[112844714]
Country of complaint: usa. Retention plates are releasing, causing the set to be contaminated. Facility implemented a preventative maintenance of lids/bottom in 2017 to be examined and repaired by aesculap. Project was completed in end of 2017. Issue is occurring with newly repaired lids and newly replaced retention plates. Rep has evaluated 2 lids/plates that customer provided, which had said issue occur last week. Rep could not locate visual issues with items, not could replicate/simulate the issue which occurred/is occurring. Frequency of occurrence - several times per week. No patient injury. A 60 minutes delay in surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00287 |
| MDR Report Key | 7652663 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-06-29 |
| Date of Report | 2018-08-21 |
| Date of Event | 2018-05-30 |
| Date Facility Aware | 2018-06-21 |
| Date Mfgr Received | 2018-06-01 |
| Date Added to Maude | 2018-06-29 |
| 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 | 1/2-SIZE LID W/RETENTION PLATE SILVER |
| Generic Name | LIDS BASIS |
| Product Code | FRG |
| Date Received | 2018-06-29 |
| Returned To Mfg | 2018-06-27 |
| Model Number | JK389 |
| Catalog Number | JK389 |
| 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 | 2018-06-29 |