MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-03 for LIGASURE LF1637 manufactured by Stryker Sustainability Solutions, Inc..
[122668844]
A ligasure blunt tip laparoscopic sealer/divider 5mm x 37cm was opened to the field and connected to the ligasure unit. Dr. Attempted to use the unit when an error code came up reading as follows, "seal not complete, please attempt to seal device again. " dr. Attempted to reseal device and it did not work. Unit was disconnected and reconnected and still did not seal properly. A new device was opened and worked well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7929978 |
| MDR Report Key | 7929978 |
| Date Received | 2018-10-03 |
| Date of Report | 2018-09-05 |
| Date of Event | 2018-08-22 |
| Report Date | 2018-09-05 |
| Date Reported to FDA | 2018-09-05 |
| Date Reported to Mfgr | 2018-09-21 |
| Date Added to Maude | 2018-10-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | 3 |
| Brand Name | LIGASURE |
| Generic Name | ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES, LAPAROSCOPIC ENDOSCOPIC |
| Product Code | NUJ |
| Date Received | 2018-10-03 |
| Catalog Number | LF1637 |
| Lot Number | 8603165 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SUSTAINABILITY SOLUTIONS, INC. |
| Manufacturer Address | 1810 W. DRAKE DR. TEMPE AZ 85283 US 85283 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-03 |