MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-20 for SURGINEEDLE 172015 manufactured by Covidien Lp Llc North Haven.
[112163374]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[112163375]
According to the reporter, during a laparoscopic cholecystectomy, the valve of the device dislodged and fell inside the patient? S cavity. It was located and removed and the case was completed. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2018-03239 |
| MDR Report Key | 7620528 |
| Date Received | 2018-06-20 |
| Date of Report | 2018-06-20 |
| Date of Event | 2018-05-24 |
| Date Mfgr Received | 2018-06-05 |
| Date Added to Maude | 2018-06-20 |
| 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 | COVIDIEN LP LLC NORTH HAVEN |
| Manufacturer Street | 195 MCDERMOTT RD |
| 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 | 0 |
| Brand Name | SURGINEEDLE |
| Generic Name | PNEUMOPERITONEUM NEEDLE |
| Product Code | FHO |
| Date Received | 2018-06-20 |
| Model Number | 172015 |
| Catalog Number | 172015 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP LLC NORTH HAVEN |
| Manufacturer Address | 195 MCDERMOTT RD NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-20 |