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 2020-03-10 for HI-LINE XS ANGLED HANDPIECE II GB757R manufactured by Aesculap Ag.
[182798527]
Associated medwatch-reports: 9610612-2020-00014 ((b)(4) gd675). Manufacturing site evaluation: we received a complaint about a gb757r - hi-line xs angled handpiece ii and a gd675 - microspeed uni xs highspeed motor. We did receive the devices in decontaminated condition for investigation. Investigation: optically, the devices are in a used condition. The investigation has been carried-out by the aesculap technical service (ats): the handpiece was distributed in april 2014 and shows a maintenance due date of 2015- 06. However, repairs can be found in the database which were executed at b. Braun sheffield. According to the database, the last repair took place in november 2019. The functional check revealed that it is not possible to clamp a tool in the handpiece. However, a running test without a tool could be executed. The handpiece became hot within a minute (41 degree). After the disassembly of the shaft, the ball bearings could be checked. Staining and corrosion was detected at the ball bearings. These residues led to a blocking of the ball bearings and therefore most likely to the mentioned heating and the improper tool clamping. Furthermore, residues can also be found inside the tool holder. Batch history review: the traceability of articles with batch management requirement is guaranteed by the production order number, which can be traced over the production period and the corresponding customer (backtrack). In addition, the raw materials, semi-finished parts, etc. Used for the order are documented in the manufacturing history records (dhr - device history records). This ensures the traceability of the internal supply and production chain. Internal traceability is thus guaranteed. Conclusion and root cause: the failure is most probably reprocessing related. Rationale: refer to investigation. Corrective action: according to sop (b)(4) a capa is not necessary.
Patient Sequence No: 1, Text Type: N, H10
[182798528]
It was reported that there was an issue with a hi-line xs angled handpiece. According to the reporter, the drill was not turning and the handpiece was overheating. The customer confirmed that another tray was opened to complete the procedure. There was no patient harm. Additional information was not provided nor available. Additional patient information is not available. The malfunction is filed under aag reference (b)(4). Associated medwatch-reports: 9610612-2020-00014 ((b)(4) gd675).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2020-00013 |
| MDR Report Key | 9813349 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2014-04-29 |
| Date Added to Maude | 2020-03-10 |
| 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 KERSTIN ROTHWEILER |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78501 |
| 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 | HI-LINE XS ANGLED HANDPIECE II |
| Generic Name | HIGHSPEED POWER SYSTEMS |
| Product Code | HBB |
| Date Received | 2020-03-10 |
| Returned To Mfg | 2020-02-12 |
| Model Number | GB757R |
| Catalog Number | GB757R |
| Lot Number | 4505683462 |
| 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 | 2020-03-10 |