MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-12 for HOUSE CURETTEDBL-ENDANG-CUPS1.5&1.8MM OG185R manufactured by Aesculap Ag.
[175859522]
Manufacturing evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[175859523]
It was reported that there was an issue with a house curette. The tip of curette broke off into patient during use. Doctor was able to retrieve broken piece. This incident did not cause or contribute to serious injury or death or a delay in surgery. The type of procedure was open reduction internal fixation (orif) left scaphoid. No patient harm was reported. Additional information was not provided. The product problem is filed under aag reference (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00626 |
| MDR Report Key | 9011080 |
| Date Received | 2019-09-12 |
| Date of Report | 2019-09-12 |
| Date of Event | 2019-08-08 |
| Date Mfgr Received | 2019-08-13 |
| Date Added to Maude | 2019-09-12 |
| 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 | 0 |
| Brand Name | HOUSE CURETTEDBL-ENDANG-CUPS1.5&1.8MM |
| Generic Name | GENERAL SURGICAL INSTRUMENTS |
| Product Code | FZS |
| Date Received | 2019-09-12 |
| Model Number | OG185R |
| Catalog Number | OG185R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-09-12 |