MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-28 for SCALPFIX STERILE FF013P manufactured by Aesculap Ag.
[30240681]
Manufacturing site evaluation: on-going.
Patient Sequence No: 1, Text Type: N, H10
[30240682]
Per facility medwatch received: there are two human factor related design issues with this product. It is difficult to count the raney clips because of the product pacakaging 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
[35326281]
(b)(4). The surgeon mentioned that the scalpfix clips are not visible in the magazine and they can therefore not be counted. During manufacturing, there is a 100% visual inspection to ensure each magazine is loaded with 10 clips. It is therefore possible to count the clips used in surgery and to calculate the remaining clips in the magazine. The intended use of the device is for clip placement prior to opening the skull and removal prior to skull closing, therefore, the clips being placed are visible at all times. The clips should not be placed within the skull, therefore, there should not be the opportunity of a retained clip. If a clip were to fall into the skull from its placed location, the size and color of the clip makes it immediately visible. It was suggested that the clips be equipped with radiopaque markers. Based on the intended use of this device, it is not necessary to equip the clips with radiopaque markers. This is not a required feature of this product as the clips are applied externally and for temporary use. If used in any other manner, it would be considered off-label. The product is not available for investigation. A review of the manufacturing process was completed. No product investigations or analyses was carried out. The batch number(s) were not reported, so the production process in general was evaluated in relation to a systematic failure. There were no indications for a systematic error during the manufacturing process. Based on the evaluation of the complaint, as noted above, no containment or other remedial action(s) is necessary. The ifu clearly describes indicators and precautions for use. There are no actions planned or implemented. According to the evaluation of the complaint there is no need for remedial action(s). This is supported by complaint trend analysis. In addition to this complaint, there have been two market feedbacks from (b)(6) (no report of incidents). Due to regulatory requirements in (b)(6) the surgery equipment must be counted before and after the surgery.
Patient Sequence No: 1, Text Type: N, H10
[35326282]
Response to request for information sent on 12/11/2015
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2015-00941 |
| MDR Report Key | 5185073 |
| Date Received | 2015-10-28 |
| Date of Report | 2015-12-30 |
| Date Mfgr Received | 2015-09-17 |
| Date Added to Maude | 2015-10-28 |
| 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 | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCALPFIX STERILE |
| Generic Name | DISPOSABLE SCALP CLIPS |
| Product Code | HBO |
| Date Received | 2015-10-28 |
| Model Number | FF013P |
| Catalog Number | FF013P |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-28 |