MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-16 for WOUND SUCTION DEVICE WITH VALVE 600.100 manufactured by Synthes Usa.
[26255489]
Device was used for treatment, not diagnosis. This report is for unknown ao suction/unknown lot number. (b)(6). Device is an instrument and is not implanted/explanted. Device is not expected to be returned for manufacturer review/investigation. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[26255490]
Report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the customer have an ao suctions in many of their sets and are starting to have issues with the little screw that holds in the suction tube. They are either too tight or too loose and need constant adjustment. The other day a screw was found on the floor of theatre five which turned out to have come from an ao suction. In the suction illustrated there seems to be no happy medium with the screw; it is either too loose or too tight. No patient involved in this case. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[28600855]
It is unknown when the device originally malfunctioned; however, the issue was discovered on (b)(6) 2015. There was no reported patient involvement. Device used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2015-15911 |
| MDR Report Key | 5082835 |
| Date Received | 2015-09-16 |
| Date of Report | 2015-09-03 |
| Date of Event | 2015-09-03 |
| Date Mfgr Received | 2015-10-14 |
| Date Added to Maude | 2015-09-16 |
| 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 | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WOUND SUCTION DEVICE WITH VALVE |
| Generic Name | MANUAL SURGICAL INSTRUMENT FOR GENERAL USE |
| Product Code | MJG |
| Date Received | 2015-09-16 |
| Catalog Number | 600.100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-16 |