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 2019-01-15 for TUNNELING INSTRUMENT 600MM FV004R manufactured by Aesculap Ag.
[133181126]
(b)(4). Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[133181127]
It was reported that there was an intraoperative issue with the tunneling instrument. During a vp shunt procedure on (b)(6) 2018, the white part of the tip was noted to be missing. Attempts were made to find the white part inside the abdomen since it was felt that it could have been retained there. After the operation, the patient underwent an x-ray due to the malfunction. Another surgery was planned to retrieve the missing piece. Sometime over the new year holiday, the second procedure was performed and the broken part was retrieved and removed. It was reported that the patient was recovering from the surgery. Further details have been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00021 |
| MDR Report Key | 8249231 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-15 |
| Date of Report | 2019-01-23 |
| Date of Event | 2018-12-21 |
| Date Facility Aware | 2019-01-18 |
| Date Mfgr Received | 2019-01-18 |
| Date Added to Maude | 2019-01-15 |
| 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 | 2019-01-15 |
| Model Number | FV004R |
| Catalog Number | FV004R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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. Required No Informationntervention | 2019-01-15 |