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 2019-05-02 for CASPAR RONGEURSTRSERR 3X12MM140MM FF503R manufactured by Aesculap Implaint Systems.
[144970163]
The optically, the motor is in a good condition. The lever is not fixed at the motor as intended. One repaired/maintenance can be found within our system from january 2006. No further repairs/maintenances took place in (b)(4) since that date. Currently the product shows a "2019-12" labeling as the next maintenance date, hence we assume that the motor was maintained by an external ats. It can be confirmed that the pin has come loose from the lever. The performance data are according to the specification. The bore at the lever seems to be worn. Therefore the welded joint as well as the pin becomes loose. It is possible that the worn bore was generated during a rework/maintenance procedure at the external ats. The device history records have been checked for the above mentioned lot numbers and found to be according to the specification, valid at the time of production. No further complaints registered against the same lot number (51242053). The failure is mostly probably repair/maintenance related. No capa is necessary.
Patient Sequence No: 1, Text Type: N, H10
[144970164]
It was reported that the io piece broke off inside the disc. During surgery, the pituitary forceps broke. Piece of instrument broke off inside disc space. Could not be retrieved. In attempting to remove metal piece a small disc leak encountered. It confirmed metal fragment well binded in disc. 3x does iv antibiotics. 3x doses iv antibiotics. Oral antibiotics for 5 days. Report received from a solicitors on behalf of a client (see attached). The client was admitted to hospital under the care of a consultant orthopaedic surgeon, on the (b)(6) 2017 for l4/l5 discectomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00237 |
| MDR Report Key | 8572952 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-02 |
| Date of Report | 2019-05-01 |
| Date of Event | 2019-01-25 |
| Date Facility Aware | 2019-04-03 |
| Date Mfgr Received | 2019-01-24 |
| Date Added to Maude | 2019-05-02 |
| 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 | MS. LINDSAY CHROMIAK |
| Manufacturer Street | 3773 CORPORATE PKWY |
| Manufacturer City | CENTER VALLEY PA 18034 |
| Manufacturer Country | US |
| Manufacturer Postal | 18034 |
| Manufacturer G1 | AESCULAP IMPLAINT SYSTEMS |
| 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 | CASPAR RONGEURSTRSERR 3X12MM140MM |
| Generic Name | BONE PUNCHES, RONGEURS |
| Product Code | HTX |
| Date Received | 2019-05-02 |
| Returned To Mfg | 2019-04-10 |
| Model Number | FF503R |
| Catalog Number | FF503R |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP IMPLAINT SYSTEMS |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-02 |