MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R

Model Number	LF1637
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	02/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
On 11/18/2020, stryker sustainability solutions became aware that mdr section b2.(outcomes attributed to ae) was not completed for this mdr.This supplemental mdr serves to provide this information.The reported event will continue to be monitored through post market surveillance.
Event or Problem Description
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.

• Brand Name: NA
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• MDR Report Key: 8438922
• Report Number: 0001056128-2019-00018
• Device Sequence Number: 19393733
• Product Code: NUJ
• UDI-Device Identifier: 00885825017620
• UDI-Public: 00885825017620
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/21/2021
• Device Model Number: LF1637
• Device Catalogue Number: LF1637RR
• Device Lot Number: 9204909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention