MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,health professional report with the FDA on 2014-11-06 for UNKNOWN CLIPGUN UNKNOWN-G manufactured by Medtronic Neurosurgery.
[19973483]
It was reported to medtronic neurosurgery that a clip was inadvertantly left in the patient. It was incidentally discovered in a subsequent operation at another hospital. It was also reported that there was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
[20262502]
The product was not returned. Therefore an evaluation of the device performance was not possible. A review of the manufacturing records was not possible as a lot number was not provided. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[94138639]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021898-2014-00439 |
| MDR Report Key | 4233548 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2014-11-06 |
| Date of Report | 2014-10-08 |
| Date Mfgr Received | 2014-10-08 |
| Date Added to Maude | 2014-11-07 |
| 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 | JEFFREY HENDERSON |
| Manufacturer Street | 125 CREMONA DRIVE |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal | 93117 |
| Manufacturer Phone | 8055718445 |
| Manufacturer G1 | MEDTRONIC NEUROSURGERY |
| Manufacturer Street | 125 CREMONA DRIVE |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93117 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN CLIPGUN |
| Generic Name | HEMOSTAT, SURGICAL |
| Product Code | EMD |
| Date Received | 2014-11-06 |
| Catalog Number | UNKNOWN-G |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Manufacturer Address | 125 CREMONA DRIVE GOLETA CA 93117 US 93117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-11-06 |