MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-14 for KLEPPINGER-STYLE FORCEPS 120868ZA manufactured by Synergy Health North America.
[77718886]
User facility personnel utilized another device and the procedure was completed successfully. A procedure delay was reported due to the reported event. The manufacturer of the device was notified following the reported event. The instrument was sent back to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[77718887]
The user facility reported that a piece from the instrument came into contact with the patient during a procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001055892-2017-00003 |
| MDR Report Key | 6642408 |
| Date Received | 2017-06-14 |
| Date of Report | 2017-06-14 |
| Date of Event | 2017-05-15 |
| Date Mfgr Received | 2017-05-15 |
| Date Added to Maude | 2017-06-14 |
| 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. MARINELA CEBIC |
| Manufacturer Street | 1416 DOGWOOD WAY |
| Manufacturer City | MEBANE NC 27302 |
| Manufacturer Country | US |
| Manufacturer Postal | 27302 |
| Manufacturer Phone | 9195638555 |
| Manufacturer G1 | SYNERGY HEALTH NORTH AMERICA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | KLEPPINGER-STYLE FORCEPS |
| Generic Name | KLEPPINGER-STYLE FORCEPS |
| Product Code | FDE |
| Date Received | 2017-06-14 |
| Returned To Mfg | 2017-05-22 |
| Model Number | 120868ZA |
| Catalog Number | 120868ZA |
| Lot Number | 300000747 |
| ID Number | NI |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERGY HEALTH NORTH AMERICA |
| Manufacturer Address | 1416 DOGWOOD WAY 27302 MEBANE NC 27302 US 27302 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-14 |