MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-04-23 for CRILE FORCEPS CVD 140MM BH145R manufactured by Aesculap Ag.
[144970437]
(b)(4). Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[144970438]
It was reported that there was an issue with curved criles. The patient was undergoing a coronary artery bypass graft surgery (cabg) and the hemostats did not clamp together well. It occurred during the cannulating process and the two instruments were quickly set aside due to the malfunction. The surgeon stated that they had not stayed attached 3. 0 ticrons. There was no patient harm or additional intervention needed, however, a delay was noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00285 |
| MDR Report Key | 8541707 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-23 |
| Date of Report | 2019-11-25 |
| Date of Event | 2019-03-18 |
| Date Facility Aware | 2019-04-17 |
| Date Mfgr Received | 2019-06-14 |
| Date Added to Maude | 2019-04-23 |
| 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, MO 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78501 |
| 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 | CRILE FORCEPS CVD 140MM |
| Generic Name | GENERAL SURGICAL INSTRUMENTS |
| Product Code | HRQ |
| Date Received | 2019-04-23 |
| Model Number | BH145R |
| Catalog Number | BH145R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2019-04-23 |