MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-17 for PROXISURE UNKNOWN manufactured by Ethicon Endo-surgery, Llc..
[75520031]
(b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.
Patient Sequence No: 1, Text Type: N, H10
[75520032]
It was reported that the patient underwent a gastric bypass procedure and a suturing device was used. The needle automatically advanced when it was being loaded. The procedure was completed using a competitor's device. There were no adverse patient consequences. Additional information will be requested.
Patient Sequence No: 1, Text Type: D, B5
[86915862]
Corrected information: this medwatch report is being voided as it does not meet the criteria of a reportable malfunction event. Should any additional information be provided, the file will be reviewed and updated accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005075853-2017-02614 |
| MDR Report Key | 6573021 |
| Date Received | 2017-05-17 |
| Date of Report | 2017-05-15 |
| Date of Event | 2017-05-15 |
| Date Mfgr Received | 2017-05-15 |
| Date Added to Maude | 2017-05-17 |
| 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 | MILTON GARRETT |
| Manufacturer Street | 4545 CREEK ROAD ML 120A |
| Manufacturer City | CINCINNATI OH 45242 |
| Manufacturer Country | US |
| Manufacturer Postal | 45242 |
| Manufacturer Phone | 5133378865 |
| Manufacturer G1 | ETHICON ENDO-SURGERY, LLC |
| Manufacturer Street | 475 CALLE C |
| Manufacturer City | GUAYNABO PR 00969 |
| Manufacturer Postal Code | 00969 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROXISURE UNKNOWN |
| Generic Name | TRAY, SURGICAL INSTRUMENT |
| Product Code | LRP |
| Date Received | 2017-05-17 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
| Manufacturer Address | 475 CALLE C GUAYNABO PR 00969 00969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-17 |