MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-31 for IRIS SCISSORS CVD S/S 110MM BC111R manufactured by Aesculap Ag.
[98786043]
(b)(4). Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[98786044]
Country of complaint: (b)(6). During procedure, the tip of blade was broken. The breakage was found (b)(6) 2018. The customer was not sure that the breakage was caused during maintenance or procedure at the time of finding the breakage. As there was the possibility of remaining inside a patient, the customer checked and found that the broken tip was inside the patient who had ptosis surgery on (b)(6) 2017. According to x-ray, the broken tip was around orbit. The surgery to remove the broken tip is scheduled (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00040 |
| MDR Report Key | 7232638 |
| Date Received | 2018-01-31 |
| Date of Report | 2018-02-02 |
| Date of Event | 2017-12-29 |
| Date Facility Aware | 2018-01-16 |
| Date Mfgr Received | 2018-01-12 |
| Device Manufacturer Date | 2016-12-27 |
| Date Added to Maude | 2018-01-31 |
| 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 |
| 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 | 0 |
| Brand Name | IRIS SCISSORS CVD S/S 110MM |
| Generic Name | SURGICAL SCISSORS |
| Product Code | HNF |
| Date Received | 2018-01-31 |
| Returned To Mfg | 2018-01-24 |
| Model Number | BC111R |
| Catalog Number | BC111R |
| Lot Number | 4508119663 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 MO |
| 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 | 1. Other | 2018-01-31 |