MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-20 for LF1637 LF1637RR manufactured by Stryker Sustainability Solutions Lakeland.
[139414348]
The device was returned to stryker sustainability solutions for evaluation. Visual inspection revealed there was evidence of excessive bio-burden present on the device. Upon evaluation, the device passed functional testing. The results of the visual inspection and functional testing determined that the reported event was not confirmed. A review of the dhr for the reported lot/serial number supports that the device met all inspection and test criteria prior to release from stryker. The reported event could be attributed to: ancillary equipment failure. Thumb trigger button (activation button) not engaged throughout the entire seal cycle device used on vessels thicker than 7 mm. Eschar build up on device jaws affecting performance. Environmental disturbance: noise. The instructions for use (ifu) state: do not apply additional hand force to the lever during sealing to ensure proper function. If the lever cannot be unlatched following use, open the device by forcing the lever forward from the handle. The device will no longer function properly and must be discarded. The reported event will continue to be monitored through post-market surveillance.
Patient Sequence No: 1, Text Type: N, H10
[139414349]
It was reported that the ligasure wasn't achieving a seal and the vessel was closed for approximately 30 seconds but burst open. They could not get a seal or control the bleeding and had to go from laparoscopic to open. Blood loss was not measured, however the patient did not require a transfusion. Once open, the surgeon was able to see where the bleed was coming from and control the bleed and seal the vessel. Patient was taken to icu after the procedure to recover. No further follow up is required. The patient has a history of hypertension. The surgical delay was under an hour. The longer exposure to anesthesia did not have any effects on the patient. These are commonly used devices that are readily available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001056128-2019-00018 |
| MDR Report Key | 8438922 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-20 |
| Date of Report | 2019-03-20 |
| Date of Event | 2019-02-27 |
| Date Mfgr Received | 2019-02-27 |
| Device Manufacturer Date | 2018-09-21 |
| Date Added to Maude | 2019-03-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MARISSA RICHMOND |
| Manufacturer Street | 1810 W. DRAKE DRIVE |
| Manufacturer City | TEMPE AZ 85283 |
| Manufacturer Country | US |
| Manufacturer Postal | 85283 |
| Manufacturer Phone | 8888883433 |
| Manufacturer G1 | STRYKER SUSTAINABILITY SOLUTIONS LAKELAND |
| Manufacturer Street | 5300 REGION CT |
| Manufacturer City | LAKELAND FL 33815 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33815 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R |
| Product Code | NUJ |
| Date Received | 2019-03-20 |
| Returned To Mfg | 2019-03-07 |
| Model Number | LF1637 |
| Catalog Number | LF1637RR |
| Lot Number | 9204909 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SUSTAINABILITY SOLUTIONS LAKELAND |
| Manufacturer Address | 5300 REGION CT LAKELAND FL 33815 US 33815 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-20 |