MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-04-20 for BLUNTPORT PLUS 179775P manufactured by Davis & Geck Caribe Ltd.
[106143177]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[106143178]
According to the reporter, during laparoscopic cholecystectomy, the lower seal part disengaged from the device. The status of the patient was fine.
Patient Sequence No: 1, Text Type: D, B5
[120785227]
Evaluation summary: post market vigilance (pmv) received one device. The visual inspection noted the threaded anchor was received. The gasket for the threaded anchor was cut and disengaged. The obturator was not received. The trocar, envelope seal and circular seal appeared intact. The condition in which was received precludes functional testing. 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. Replication of the cut in the circular seals may occur when mishandled during clinical application. The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[120785228]
According to the reporter, during laparoscopic cholecystectomy, the lower seal part disengaged from the device. The procedure was completed with another device. The status of the patient was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612501-2018-00808 |
| MDR Report Key | 7448844 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-04-20 |
| Date of Report | 2018-07-05 |
| Date of Event | 2018-04-09 |
| Date Mfgr Received | 2018-06-19 |
| Date Added to Maude | 2018-04-20 |
| 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 | LISA HERNANDEZ |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925563 |
| 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 | 2018-04-20 |
| Returned To Mfg | 2018-05-04 |
| Model Number | 179775P |
| Catalog Number | 179775P |
| 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 | 2018-04-20 |