MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-01 for CLIP GUN CG8900 manufactured by Medtronic Neurosurgery.
[68613033]
Patient Sequence No: 1, Text Type: N, H10
[68613034]
Unable to count raney clips because applicator is pre-loaded by the manufacturer with an inconsistent number of clips. Unable to check for retained item with imaging because clips are not radiopaque. Applicator will also drop clips in the surgical site if it is accidentally tapped, making it impossible to know how many clips have been used. The poor quality of this product and concern for patient safety is an issue for every cranioplasty case because there are no alternative products on the market. We would like to suggest that the applicator be manually loaded so that a pre-count could be performed and raney clips be included in our counting protocol. We also suggest that the clips be available in a radiopaque material so that we could capture clips on imaging in the event of an incorrect count.
Patient Sequence No: 1, Text Type: D, B5
[73940768]
Patient Sequence No: 1, Text Type: N, H10
[73940769]
While investigating ways to prevent retained raney clips, surgeons reported challenges related to counting this item: the clip applicator is pre-loaded by the manufacturer with an inconsistent number of clips (usually +/- 1 or 2) and cannot be counted in the pre-count. The gun sometimes releases more than one clip (this may be that the user was holding down the trigger or the trigger was overly sensitive). Because of these challenges with counting the clips, the surgical team would like a radiopaque option for raney clips so that x-ray may be used to check for retained clips.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6367797 |
| MDR Report Key | 6367797 |
| Date Received | 2017-03-01 |
| Date of Report | 2017-01-30 |
| Date of Event | 2016-02-09 |
| Report Date | 2017-01-24 |
| Date Reported to FDA | 2017-01-24 |
| Date Reported to Mfgr | 2017-01-24 |
| Date Added to Maude | 2017-03-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLIP GUN |
| Generic Name | CLIP, SCALP |
| Product Code | HBO |
| Date Received | 2017-03-01 |
| Model Number | CG8900 |
| Catalog Number | CG8900 |
| Device Availability | * |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-03-01 |