MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-02 for LF1737 LF1737RR manufactured by Stryker Sustainability Solutions Lakeland.
[182560294]
The device was returned to stryker sustainability solutions for evaluation. The device evaluation is currently in progress. A supplemental mdr will be submitted once the device evaluation is completed. The reported event will continue to be monitored through post-market surveillance.
Patient Sequence No: 1, Text Type: N, H10
[182560295]
It was reported half way into the case while sealing a pancreatic artery during distal pancreatectomy procedure, the generator gave error code 403 on the ft10 generator to inspect seal, check for metal clips/staples, remove excess fluids. There was 300 cc's of blood loss and no transfusion was needed. The device was replaced to successfully complete the procedure. There was no patient injury and extended procedure time reported was minimal at 10 minutes to stop the bleeding and replace device. These are commonly used devices that are readily available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001056128-2020-00001 |
| MDR Report Key | 9541875 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-02 |
| Date of Report | 2020-02-05 |
| Date of Event | 2019-12-03 |
| Date Mfgr Received | 2020-01-09 |
| Device Manufacturer Date | 2019-08-09 |
| Date Added to Maude | 2020-01-02 |
| 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 | 2020-01-02 |
| Returned To Mfg | 2019-12-09 |
| Model Number | LF1737 |
| Catalog Number | LF1737RR |
| Lot Number | 10707376 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 1. Required No Informationntervention | 2020-01-02 |