MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2010-02-24 for ONEPORT 5-11MM TROCAR W/CONICAL DILATING TIP DT-11R manufactured by Conmed Corp..
[16044502]
It was reported by facility that "clear plastic part of the seal broke and fell into patient while inserting, the jaws of clip applier was catching onto the seal".
Patient Sequence No: 1, Text Type: D, B5
[16094733]
When the quality engineer has completed the investigation, we will file a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1320894-2010-00019 |
| MDR Report Key | 1619169 |
| Report Source | 06,07 |
| Date Received | 2010-02-24 |
| Date of Report | 2010-02-23 |
| Date of Event | 2009-11-16 |
| Date Mfgr Received | 2010-01-29 |
| Date Added to Maude | 2011-01-31 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | TYLER CORCORAN |
| Manufacturer Street | 525 FRENCH RD. |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal | 13502 |
| Manufacturer Phone | 3156243059 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONEPORT 5-11MM TROCAR W/CONICAL DILATING TIP |
| Generic Name | DILATING TROCAR W/RIBBED CANNULA |
| Product Code | FBM |
| Date Received | 2010-02-24 |
| Model Number | NA |
| Catalog Number | DT-11R |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORP. |
| Manufacturer Address | UTICA NY 13502 US 13502 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-02-24 |