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 2019-02-14 for TUNNELING INSTRUMENT 600MM FV004R manufactured by Aesculap Ag.
[139337788]
(b)(4). Manufacturing site evaluation: no device was returned: an evaluation was not performed. If additional information become available, it will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[139337789]
It was reported that there was an intraoperative issue with the tunneling instrument and progav insertion. The handle wings broke during use in a hydrocephalus valve/shunt placement procedure on a patient with normal pressure hydrocephalus (nph). The tunneling instrument was being used to attempt to access the abdomen (going behind the ear to the abdomen without a release cut). The surgeon was noted as pulling with enormous power when both handle wings broke and then a small piece of a handle remained at the trocar. Nevertheless, the surgeon pulled through the peritoneal catheter; however, the catheter was damaged and removed and a different progav was opened and implanted. There was a delay of about 30 minutes in the operation but no harm to the patient was reported. Additional information is not available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00047 |
| MDR Report Key | 8340206 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-14 |
| Date of Report | 2019-02-14 |
| Date Facility Aware | 2019-01-24 |
| Date Mfgr Received | 2013-11-11 |
| Date Added to Maude | 2019-02-14 |
| 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 | 2019-02-14 |
| Model Number | FV004R |
| Catalog Number | FV004R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-02-14 |