MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-14 for MNS UNKNOWN CLIPGUN UNKNOWN-G manufactured by Medtronic Neurosurgery.
[36028164]
It is unknown whether the reported device was a medtronic product. The product was unavailable for return. Therefore an evaluation of device performance was not possible. A review of the manufacturing records was not possible as no lot number was provided. The instructions for use that accompany the medtronic clip gun kit specify that the clip gun kit containing a clip gun, pre-loaded magazines with scalp clips, and removal forceps is a single-use disposable kit. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[36028165]
It was reported to medtronic neurosurgery that the patient was admitted to the hospital for removal of two melanoma metastases to the right occipital and the right parietal lobes of his brain. Reportedly, the patient had 2 craniotomies, and during both of these operations raney clips were used to compress the layers of the scalp in order to stop it from bleeding and to keep the scalp out of the surgical area. According to the report, the patient returned to surgery for a craniotomy and a wound irrigation and drainage with removal of the bone flap. The neurosurgeon's note stated there were signs of infection so he took cultures and then irrigated the wound with two different antibiotic solutions. It was reported that during the irrigation, a green raney clip was found floating in the irrigant and because clips had not been applied to the skin edge during the current wound washout, it was possible that the clip was remnant from the prior operation, and it was removed. Reportedly, a drain was placed in the surgical area to drain cerebral spinal fluid and residual infection.
Patient Sequence No: 1, Text Type: D, B5
[94196535]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021898-2016-00021 |
| MDR Report Key | 5368867 |
| Date Received | 2016-01-14 |
| Date of Report | 2015-12-15 |
| Date Mfgr Received | 2015-12-15 |
| Date Added to Maude | 2016-01-14 |
| 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 |
| 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 | 0 |
| Brand Name | MNS UNKNOWN CLIPGUN |
| Generic Name | CLIP, SCALP |
| Product Code | HBO |
| Date Received | 2016-01-14 |
| Catalog Number | UNKNOWN-G |
| 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 | 2016-01-14 |