MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-27 for CHISEL ANG 10MM 140MM FL126R manufactured by Aesculap Ag.
[139343467]
It was reported that we received a complaint about five mislabeled chisel. The instrument was are labelled with 6 instead of 10. The failure was noticed preoperatively, since all product were provided in the unopened packaging. Five uncontaminated chisels are available for investigation. According to the available information, there were no negative consequences for the patient. The instruments are new and originals sealed, but are labelled with "6" instead of "10". No other deviation can be found. The employees at the production plant confirmed the faulty labelling. The affected labeling is applied manually and can be traced back to a human error. The employees have already been trained. The device quality manufacturing history records have been checked for the available lot numbers and found to be according to our specifications valid at the time of production. No similar incidents have been filed with products from this batch. Based on the information available as well as a result of our investigation the root causes of the failure is related to a manufacturing error. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[139343468]
It was reported that we received a complaint about five mislabeled chisel. The instrument was are labelled with 6 instead of 10. The failure was noticed preoperatively, since all product were provided in the unopened packaging. Five uncontaminated chisels are available for investigation. According to the available information, there were no negative consequences for the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00108 |
| MDR Report Key | 8373705 |
| Date Received | 2019-02-27 |
| Date of Report | 2019-02-27 |
| Date Facility Aware | 2018-12-11 |
| Date Mfgr Received | 2019-02-05 |
| Device Manufacturer Date | 2018-12-11 |
| Date Added to Maude | 2019-02-27 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| 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 | 0 |
| Brand Name | CHISEL ANG 10MM 140MM |
| Generic Name | GENERAL SURGICAL INSTRUMENTS |
| Product Code | FZO |
| Date Received | 2019-02-27 |
| Returned To Mfg | 2019-02-12 |
| Model Number | FL126R |
| Catalog Number | FL126R |
| Lot Number | 4510180122 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-02-27 |