MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-09-27 for TUNNELING INSTRUMENT 600MM FV004R manufactured by Aesculap Ag.
[122008677]
(b)(4). Manufacturing site evaluation: only four primary sterile packaging and one secondary packaging of the instruments have been provided for investigation. They arrived in a clean status with visible damages. The instruments and the other sterile packaging are missing. The components have been examined visually and microscopically with the digital microscope and digital camera. A visual inspection of the primary sterile packaging and found a ripped sterile packaging. Additionally found the ripped off foil of the primary sterile packaging. A visual inspection of the secondary sterile packaging, also found a ripped sterile packaging. The root cause of the problem is most probably usage related. A capa is not necessary.
Patient Sequence No: 1, Text Type: N, H10
[122008678]
It was reported by the healthcare professional to the company sales representative that during a surgical procedure, while opening the package and passing it to the surgeon the foil ripped causing the instrument to be contaminated. Another device was immediately available, no surgery delay, no patient harm was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00434 |
| MDR Report Key | 7915121 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-09-27 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-09-06 |
| Date Facility Aware | 2018-09-13 |
| Date Mfgr Received | 2018-09-06 |
| Device Manufacturer Date | 2018-07-31 |
| Date Added to Maude | 2018-09-27 |
| 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 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 | TUNNELING INSTRUMENT 600MM |
| Generic Name | HYDROCEPHALUS VALVES |
| Product Code | HAO |
| Date Received | 2018-09-27 |
| Returned To Mfg | 2018-09-17 |
| Model Number | FV004R |
| Catalog Number | FV004R |
| Lot Number | 52348165 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 YR |
| 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 | 2018-09-27 |