MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-08 for CALIPER IN & OUT DIA TO 150MM AA846R manufactured by Aesculap Ag.
[138527322]
(b)(4). The two calipers are in a mint condition, but two adjustments screws and one guiding screw are not in place. Only one of the adjustment screws was provided, the other adjustment screw and the guiding screw are missing. Vigilance investigator carried out the pictorial documentation visually and microscopically. A caliper "a" one of the adjustment screws is not in place. At caliper "b" one of the adjustment screws and guiding screw are not in place. It is no longer traceable from to which caliper the provided screw belongs to. A review of the device quality and manufacturing history records was not possible because the lot number is unknown. Based on the information available as well as a result of the investigation the root cause of the failure is most probably related to an insufficient usage.
Patient Sequence No: 1, Text Type: N, H10
[138527323]
It was reported by the healthcare professional "the screw was loose and this made is impossible to use the caliper. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00171 |
| MDR Report Key | 8404048 |
| Date Received | 2019-03-08 |
| Date of Report | 2019-03-07 |
| Date Facility Aware | 2019-03-07 |
| Date Mfgr Received | 2019-02-07 |
| Date Added to Maude | 2019-03-08 |
| 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 | CALIPER IN & OUT DIA TO 150MM |
| Generic Name | GENERAL SURGICAL INSTRUMENTS |
| Product Code | HOE |
| Date Received | 2019-03-08 |
| Returned To Mfg | 2019-03-06 |
| Model Number | AA846R |
| Catalog Number | AA846R |
| 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 | 2019-03-08 |