MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-10 for LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/ DIVIDER LF1837 manufactured by Covidien Llc.
[108152591]
Covidien ligasure blunt tip laparoscopic sealer/divider handpiece was plugged into ligasure generator and was recognized by the unit, but upon attempting activation by the surgeon, the handpiece would not work. The instrument was unplugged and plugged back in, but this did not work. I retrieved another ligasure generator and plugged the handpiece into that machine, but again the handpiece would not work. I opened a third ligasure hand piece, which then worked.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077132 |
| MDR Report Key | 7506233 |
| Date Received | 2018-05-10 |
| Date of Report | 2018-05-08 |
| Date of Event | 2018-05-08 |
| Date Added to Maude | 2018-05-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/ DIVIDER |
| Generic Name | LIGASURE |
| Product Code | NUJ |
| Date Received | 2018-05-10 |
| Model Number | LF1837 |
| Catalog Number | LF1837 |
| Lot Number | 73520526X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LLC |
| Manufacturer Address | MANSFIELD MA 02048 US 02048 |
| Brand Name | LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/ DIVIDER |
| Generic Name | LIGASURE |
| Product Code | NUJ |
| Date Received | 2018-05-10 |
| Model Number | LF1837 |
| Catalog Number | LF1837 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-10 |