MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-21 for DISP.TROCAR THRD.W.DILATING PIN 12/110MM EK236SU manufactured by Aesculap Ag.
[44164922]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[44164923]
Country of complaint: (b)(6). During insertion of the pg036su / disp. Sucti. /irrig. Instr. 5/330mm w. Spike the tip of the trocar (ek236su / disp. Trocar thrd. W. Dilating pin) broke into 3 parts, falling in the body of the patient. The caliber was the smallest possible and the operator didn't apply any type of force on the instrument. It was difficult to find all pieces since it is not radiopaque.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2016-00309 |
| MDR Report Key | 5594862 |
| Date Received | 2016-04-21 |
| Date of Report | 2017-07-14 |
| Date of Event | 2016-02-24 |
| Date Facility Aware | 2016-04-21 |
| Date Mfgr Received | 2016-03-21 |
| Date Added to Maude | 2016-04-21 |
| 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 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 | 0 |
| Brand Name | DISP.TROCAR THRD.W.DILATING PIN 12/110MM |
| Generic Name | TROCAR |
| Product Code | FBQ |
| Date Received | 2016-04-21 |
| Model Number | EK236SU |
| Catalog Number | EK236SU |
| Lot Number | 52158042 |
| Device Availability | * |
| 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 | 2016-04-21 |