MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-24 for RANEY CLIP FF013P manufactured by Aesculap, Inc..
[26650141]
Patient Sequence No: 1, Text Type: N, H10
[26650142]
There are two human factor related design issues with this product: it is difficult to count the raney clips because of the product packaging design. It is challenging to complete an accurate initial count because the packaging does not allow visibility of all the clips before opening. The product is; 1 magazine, 10 clips. The product should have radiopaque markers for visibility under x-ray and to aid in preventing retained surgical items. This has happened multiple times where the patient was sent to ct, when a clip was found missing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5100571 |
| MDR Report Key | 5100571 |
| Date Received | 2015-09-24 |
| Date of Report | 2015-08-25 |
| Date of Event | 2015-07-01 |
| Report Date | 2015-08-25 |
| Date Reported to FDA | 2015-08-25 |
| Date Reported to Mfgr | 2015-08-25 |
| Date Added to Maude | 2015-09-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | RANEY CLIP |
| Generic Name | CLIP, SCALP, RANEY |
| Product Code | HBO |
| Date Received | 2015-09-24 |
| Model Number | FF013P |
| Catalog Number | FF013P |
| Lot Number | UNKNOWN |
| ID Number | FF013P |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP, INC. |
| Manufacturer Address | 3773 CORPORATE PKWY. CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-24 |