MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-29 for BLADE, CAROL GIRARD 99-584-24-02 manufactured by Karl Leibinger Medizintechnik Gmbh & Co. Kg.
[125431675]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[125431676]
Screw driver blade broke during use. All pieces were removed.
Patient Sequence No: 1, Text Type: D, B5
[132430535]
An investigation was performed on the basis of complaint statistics as no device was returned for evaluation. The complaint percentage falls within the design risk limits adhered to at klm. The review of the device history records was not possible due to no lot number being identified. Due to no device being returned the failure root cause cannot be determined. If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610905-2018-00262 |
| MDR Report Key | 8016723 |
| Date Received | 2018-10-29 |
| Date of Report | 2018-10-02 |
| Date of Event | 2018-10-02 |
| Date Facility Aware | 2018-12-20 |
| Report Date | 2018-10-02 |
| Date Reported to Mfgr | 2018-10-02 |
| Date Mfgr Received | 2018-12-20 |
| Date Added to Maude | 2018-10-29 |
| 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. JENNIFER DAMATO |
| Manufacturer Street | P.O. BOX 16369 |
| Manufacturer City | JACKSONVILLE FL 32245 |
| Manufacturer Country | US |
| Manufacturer Postal | 32245 |
| Manufacturer Phone | 9046417746 |
| Manufacturer G1 | KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG |
| Manufacturer Street | KOLBINGER STRASSE 10 |
| Manufacturer City | MUEHLHEIM/DONAU, 78570 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78570 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BLADE, CAROL GIRARD |
| Generic Name | CAROL GIRARD |
| Product Code | HWJ |
| Date Received | 2018-10-29 |
| Model Number | 99-584-24-02 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG |
| Manufacturer Address | KOLBINGER STRASSE 10 MUEHLHEIM/DONAU, 78570 GM 78570 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-29 |