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 2019-04-23 for TUNNELING INSTRUMENT 600MM FV004R manufactured by Aesculap Ag.
[142821919]
(b)(4). If additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[142821920]
It was reported the tip of the instrument broke and fell into the patient intra-operatively. The reporter indicated the tip of the device detached from the device and remained in the patient's body. It is unknown if the cord broke apart or the tip itself broke. The tip was removed from the patient, and the surgical procedure was completed. Additional information has been requested, however, not yet received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00262 |
| MDR Report Key | 8541915 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-23 |
| Date of Report | 2019-05-28 |
| Date of Event | 2019-03-26 |
| Date Facility Aware | 2019-05-16 |
| Date Mfgr Received | 2019-05-16 |
| Device Manufacturer Date | 2018-11-20 |
| Date Added to Maude | 2019-04-23 |
| 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. LINDSAY CHROMIAK |
| Manufacturer Street | 3773 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY PA 18034 |
| Manufacturer Country | US |
| Manufacturer Postal | 18034 |
| Manufacturer Phone | 8002581946 |
| 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 MANAGEMENT |
| Product Code | HAO |
| Date Received | 2019-04-23 |
| Returned To Mfg | 2019-04-11 |
| Model Number | FV004R |
| Catalog Number | FV004R |
| Lot Number | 52468257 |
| 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. Required No Informationntervention | 2019-04-23 |