MAUDE Adverse Event Report: STRYKER-ENDOSCOPY LAKELAND 5300; ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R

Catalog Number	LF1837
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a lap assist vaginal hysterectomy with bilateral salpingo oophorectomy, the surgeon said the ligasure was not sealing as it typically did through the case.End tone and energy delivery was noted; no re-grasp alert occurred.The cleaning of the jaws of the ligasure handpiece was performed frequently, as always.Initially, several good seals were completed successfully, however, by the time the procedure reached the uterine and cervix, the previous seals began to come apart and started bleeding so much that the procedure had to convert to open.It was also reported that a a different device was used and it worked fine according to the surgeon.As reported, the tissue bundle was not thick, as the uterine tissues had been skeletonized.Patient experienced a blood loss of 900 milliliters and will be given a blood transfusion once on the floor of the hospital.Patient hospitalization was extended of one week.Patient had a small bowel obstruction during this time too.The patient is currently healing, though the recovery process has been lengthy.The generator used in the event worked okay with other procedures/ligasures devices.There was no other patient injury or medical intervention reported and the complainant is not aware of any extended procedure time.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation.The submitted medwatch form did not specify the availability of the device for return.As the device was not returned for evaluation, inspection was unable to be performed.The customer did not report lot # or serial # information.Therefore, the device history record (dhr) was unable to be verified.Stryker procedure(s) support(s) that the device was unlikely to have been released from stryker with the reported failure mode.The reported event could be attributed to: - spacer pad damage - ancillary equipment failure - device activated in contact with pooling fluid.- device used on vessels thicker than 7 mm.- grasping on too much tissue or inappropriate tissue types or on staples.- trigger button (activation button) not engaged throughout the entire seal cycle.The instructions for use (ifu) state: - do not place the vessel and/or tissue in the jaw hinge.Place the vessel and/or tissue in the center of the jaws.- do not use this instrument on vessels larger than 7 mm in diameter.- if the instrument shaft is visibly bent, discard and replace the instrument.A bent shaft may prevent the instrument from sealing or cutting properly.- eliminate tension on the tissue when sealing and cutting to ensure proper function.- use caution when grasping, manipulating, sealing, and dividing large tissue bundles.- do not attempt to seal or cut over clips or staples as incomplete seals will be formed.Contact between an active electrode and any metal objects may result in alternate site burns or incomplete seals.- do not activate the ligasure system until the lever has been latched.Activating the system before latching may result in improper sealing and may increase thermal spread to tissue outside of the surgical site.- prior to cutting the seal, inspect the vessel or tissue to ensure proper sealing.- keep the instrument jaws clean.Build-up of eschar may reduce the seal and/or cutting effectiveness.Wipe jaw surfaces and edges with a wet gauze pad as needed.- if the generator provides multiple power settings, use the lowest power needed to achieve the intended effect.- do not overfill the jaws of the instrument with tissue, as this may reduce device performance.- use caution during surgical procedures in which patients exhibit certain types of vascular pathology (atherosclerosis, aneurysmal vessels, etc.).For best results, apply the seal to unaffected vasculature.- energy-based devices, such as es pencils or ultrasonic scalpels that are associated with thermal spread, should not be used to transect seals.The reported event will continue to be monitored through post-market surveillance.Should the device become available for return, the investigation will be reopened.

• Brand Name: NA
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R
• Manufacturer (Section D): STRYKER-ENDOSCOPY LAKELAND 5300; 5300 region ct; lakeland FL 33815
• Manufacturer (Section G): STRYKER-ENDOSCOPY LAKELAND 5300; 5300 region ct; lakeland FL 33815
• Manufacturer Contact: arsalan rizvi ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 24203504
• Report Number: 0001056128-2026-00007
• Device Sequence Number: 5484071
• Product Code: NUJ
• UDI-Device Identifier: 07613327500844
• UDI-Public: 07613327500844
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/28/2026

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?: Yes
• Device Catalogue Number: LF1837
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown