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 2019-03-27 for JAW INS.BIOPSY FCPS W/TEETH 5MM 310MM PO652R manufactured by Aesculap Ag.
[140145870]
When new information becomes available a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[140145871]
It was reported that during a laparoscopic hysterectomy procedure one of the two tooth's detached from the biopsy forceps and fell into the patient. It was retrieved. This incident did not cause or contribute to serious injury or death or a delay in surgery. No other information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00221 |
| MDR Report Key | 8458204 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-27 |
| Date of Report | 2019-05-07 |
| Date of Event | 2019-02-28 |
| Date Facility Aware | 2019-04-18 |
| Date Mfgr Received | 2019-04-18 |
| Date Added to Maude | 2019-03-27 |
| 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. 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 | 3 |
| Brand Name | JAW INS.BIOPSY FCPS W/TEETH 5MM 310MM |
| Generic Name | REUSABLE INSTRUMENTS |
| Product Code | KNF |
| Date Received | 2019-03-27 |
| Model Number | PO652R |
| Catalog Number | PO652R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-03-27 |