MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-23 for JENKNER TUNNELER W/CONI-TIP 500X12MM FC005R manufactured by Aesculap Ag.
[29332172]
Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[29332173]
Country of complaint: (b)(6). Intra-operative customer returned handle and tunneller separately. Both devices were used in the surgical procedure. This device product # fc005r_jenkner tunneler w/coni-tip 500x12mm is associated with medwatch # 2916714-2015-00937_ product fc030_jenkner tunneler handle. During a vascular case customer was using the aesculap tunneller. According to the customer the item was checked by the scrub nurse and surgeon before use. However during the procedure the olive tip became detached inside the patient which necessitated a minor incision to retrieve same. This caused a 10 minute delay in the procedure. Clinical nurse manager give response regarding additional incision superficial skin incision to retrieve the olive tip and no further information forthcoming.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2015-00936 |
| MDR Report Key | 5171644 |
| Date Received | 2015-10-23 |
| Date of Report | 2015-10-22 |
| Date of Event | 2015-09-18 |
| Date Mfgr Received | 2015-09-22 |
| Date Added to Maude | 2015-10-23 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | 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 | JENKNER TUNNELER W/CONI-TIP 500X12MM |
| Generic Name | DILATORS, CATHETERS |
| Product Code | GCC |
| Date Received | 2015-10-23 |
| Model Number | FC005R |
| Catalog Number | FC005R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-10-23 |