MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-03-24 for RANEY SCALP CLIPS 20-1037 manufactured by Codman & Shurtleff, Inc..
[71048494]
(b)(4). Upon completion of the investigation a follow up report will be filed. Device not available.
Patient Sequence No: 1, Text Type: N, H10
[71048575]
It was reported that the clip, which was repackaged and sold by a company called hogy medical, was cracked during a surgery when the surgeon was attempting to open the clip by using another manufacturer? S forceps. The forceps? Manufacturer is named eagle industries. It was suspected that the crack occurred due to the incompatibility of the used forceps with the clip. The same events occurred for multiple times since (b)(6) 2016 at the same hospital, and this was the first time to be notified to (b)(4). It is confirmed that the eagle industries? Forceps was used for all cases. There is a possibility that a broken fragment left in the patient? S body, but at this time, no adverse events are reported. No further information is provided by the hospital. Several potential lot numbers have been provided; however, the initial reported was not able to identify which specific lot number was affected.
Patient Sequence No: 1, Text Type: D, B5
[75455443]
It was stated that the device was resold after being repackaged by another company. The labeling for the device indicates that the device is a single-use, sterile product and should not be resterilized. Several potential lot numbers have been provided; however, the initial reported was not able to identify which specific lot number was affected. A review of the manufacturing records for the potential lots was performed, and no discrepancies were noted. Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed. The cause(s) of the difficulty reported by the customer could not be determined. If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed. Trends will be monitored for this or similar complaints. At present, we consider this complaint to be closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2017-10179 |
| MDR Report Key | 6432626 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-03-24 |
| Date Mfgr Received | 2017-04-18 |
| Date Added to Maude | 2017-03-24 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR JAMES KENNEY |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088282726 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RANEY SCALP CLIPS |
| Generic Name | CLIPS, SCALP |
| Product Code | HBO |
| Date Received | 2017-03-24 |
| Catalog Number | 20-1037 |
| Lot Number | UNK, MULTIPLE LOT CODES GIVEN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-24 |