MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2015-01-20 for BLTPRT PLUS 12MM OBTR + 5MM-12MM SEAL RT 179775P manufactured by Covidien.
[5420345]
Procedure: gynecology. According to the reporter: upon manipulation of the blunt grip, the inner part of the obtulator happened to be broken. A new one was opened and then the same event occurred consecutively. Operating time not extended. New one was opened to complete the case with no problem. No patient harm.
Patient Sequence No: 1, Text Type: D, B5
[12924074]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[13232824]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612501-2015-00029 |
| MDR Report Key | 4433742 |
| Report Source | 01,06 |
| Date Received | 2015-01-20 |
| Date of Report | 2015-01-07 |
| Date of Event | 2014-12-19 |
| Date Mfgr Received | 2015-01-07 |
| Device Manufacturer Date | 2014-04-30 |
| Date Added to Maude | 2015-02-18 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 |
| Manufacturer Street | ZONA FRANCA DE SAN ISIDRO CARRETARA SAN ISIDRO KM17 |
| Manufacturer City | SANTO DOMINGO |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLTPRT PLUS 12MM OBTR + 5MM-12MM SEAL RT |
| Generic Name | DISPOSABLE SURGICAL ACCESS DEVICE |
| Product Code | GDH |
| Date Received | 2015-01-20 |
| Returned To Mfg | 2015-02-05 |
| Model Number | 179775P |
| Catalog Number | 179775P |
| Lot Number | J4D1539X |
| Device Expiration Date | 2019-04-30 |
| 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 |
| Manufacturer Address | ZONA FRANCA DE SAN ISIDRO CARRETARA SAN ISIDRO KM17 SANTO DOMINGO DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-20 |