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 2019-04-24 for CASPAR RONGEUR UP-BITE 3MM155MM FF843R manufactured by Aesculap Ag.
[143030569]
(b)(4). Manufacturing site evaluation: the instruments were not available for investigation. Batch history review - the product does not require batch management; a review of the device quality and manufacturing history records is not possible. Conclusion and root cause - no product available and therefore it is hardly possible to determine an exact conclusion and root cause. We assume that the cause of the failure is not product related. There is the possibility that the root cause of the problem is most probably usage related. Rationale - according to the quality standard a material defect and production error can be excluded. Without the product we cannot determine the exact cause. There is the possibility for a usage error due to improper handling or mechanical overload situation by torsion or high leverage with the instrument. According to the intended use: indication- the aesculap ronguers are used to remove soft tissue (e. G. Intervertebral disc tissue, mucous membrane, ethmoidal cells, cell tissue, nucleus tissue, sequester) in neuro and spinal surgery. Contraindication- the dismountable aesculap rongeurs are not suitable for removing bone or adjacent bone structures! For this purpose, we recommend the use of bone punches that can withstand higher mechanical loads. Due to the provided information... "the customer scraped the disc"... There is the possibility that the instrument was not used for its intended purpose. There is also the possibility that during scraping the movable open jaw may have been broken by lateral forces due to an overload. Possibly the instruments have been used to lever or scrape bones or adjacent bone structures. If further investigations are required, the product should be provided for examination. Furthermore, according to the instructions for use (ifu) the following points and caution must be observed: caution - damage or destruction of the jaws due to overload!
Patient Sequence No: 1, Text Type: N, H10
[143030570]
It was reported that there was an issue with the caspar rongeur. During an unspecified procedure, two instruments broke; this occurred while scraping the disc. It was noted that the surgeon had not used the correct one and had to use a more resistant instrument. There was no delay in surgery. An x-ray was necessary in order to continue with the surgery. The breakage had been clean with only 1 piece separated. The piece from the devices was easily retrieved and removed. Additional information was not provided. Associated medwatches: 9610612-2019-00274.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00298 |
| MDR Report Key | 8546314 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-24 |
| Date of Report | 2019-04-24 |
| Date of Event | 2018-01-30 |
| Date Facility Aware | 2019-04-18 |
| Date Mfgr Received | 2019-04-08 |
| Date Added to Maude | 2019-04-24 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | CASPAR RONGEUR UP-BITE 3MM155MM |
| Generic Name | MICRO NEUROSURGICAL INSTR. |
| Product Code | HTX |
| Date Received | 2019-04-24 |
| Model Number | FF843R |
| Catalog Number | FF843R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2019-04-24 |