MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-09-06 for SILSPORT 12 TEM INDICATION SILSPT12TA manufactured by Covidien, Formerly Us Surgical A Divison.
[53941249]
(b)(4). Additional attempts to obtain information and the device have been made. A supplemental report will be submitted with new details if they become available
Patient Sequence No: 1, Text Type: N, H10
[53941250]
According to the reporter, one of trocars was broken when package was opened.
Patient Sequence No: 1, Text Type: D, B5
[56562051]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[69464320]
(b)(4). Post market vigilance (pmv) led an evaluation one device. The initial visual inspection of the sample by the pmv investigator noted the flexible sils port was not received. The cannula with the luer lock had a disengaged circular seal. Product analysis suggests the product was used in a surgical procedure. It is possible that the separation of the cap from the cannula is the result of rough handling. The product analysis concluded there were no device abnormalities that would have caused or contributed to the reported incident. No enhancements or improvements were generated for the reported condition. Should new information become available, the file will be re-opened and reassessed at that time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219930-2016-00935 |
| MDR Report Key | 5928907 |
| Report Source | USER FACILITY |
| Date Received | 2016-09-06 |
| Date of Report | 2016-08-11 |
| Date Mfgr Received | 2017-03-08 |
| Device Manufacturer Date | 2015-08-01 |
| Date Added to Maude | 2016-09-06 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN, FORMERLY US SURGICAL A DIVISON |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06473 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILSPORT 12 TEM INDICATION |
| Generic Name | ANOSCOPE AND ACCESSORIES |
| Product Code | FER |
| Date Received | 2016-09-06 |
| Returned To Mfg | 2016-09-12 |
| Model Number | SILSPT12TA |
| Catalog Number | SILSPT12TA |
| Lot Number | N5H0985X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN, FORMERLY US SURGICAL A DIVISON |
| Manufacturer Address | 60 MIDDLETOWN AVE NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-06 |