MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2017-12-18 for BLUNTPORT PLUS 179775P manufactured by Davis & Geck Caribe Ltd.
[95189441]
Patient Sequence No: 1, Text Type: N, H10
[95189442]
According to the reporter, during laparoscopic choledocholithotomy, device was not used due to deformed part. It was difficult to set in the outer cylinder.
Patient Sequence No: 1, Text Type: D, B5
[121921814]
Evaluation summary: post market vigilance (pmv) received one device. The visual inspection noted; the threaded anchor, obturator, insufflation port and envelope seal all appeared intact. The cannula was not received. An air leak test could not be performed due to the missing cannula. All other components functioned properly. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. Analysis concluded there were no assembly component related failures. Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612501-2017-06790 |
| MDR Report Key | 7126609 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2017-12-18 |
| Date of Report | 2018-02-06 |
| Date of Event | 2017-11-22 |
| Date Mfgr Received | 2018-01-27 |
| Device Manufacturer Date | 2017-01-23 |
| Date Added to Maude | 2017-12-18 |
| 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 | 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 | DAVIS & GECK CARIBE LTD |
| Manufacturer Street | ZONA FRANCA DE SAN ISIDRO |
| Manufacturer City | SANTO DOMINGO 0101 |
| Manufacturer Country | DO |
| Manufacturer Postal Code | 0101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLUNTPORT PLUS |
| Generic Name | GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GDH |
| Date Received | 2017-12-18 |
| Returned To Mfg | 2017-12-27 |
| Model Number | 179775P |
| Catalog Number | 179775P |
| Lot Number | J7A1320X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAVIS & GECK CARIBE LTD |
| Manufacturer Address | ZONA FRANCA DE SAN ISIDRO SANTO DOMINGO 0101 DO 0101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-18 |