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.
[5066978]
It was reported to medtronic neurosurgery that a clip was inadvertently left in a patient. The patient was initially operated on (b)(6) 2014. For unrelated reasons to the clip, she was reoperated on (b)(6) 2014. The clip was discovered to be left in the patient during the second operation. It was also reported that there was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
[12439760]
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
[94139410]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021898-2014-00440 |
| MDR Report Key | 4233592 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2014-11-06 |
| Date of Report | 2014-10-08 |
| Date of Event | 2014-08-07 |
| 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 |