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

Model Number	LF1212A
Medical Device Problem Codes	Contamination (1120); Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Unspecified Infection (1930); Insufficient Information (4580)
Date of Event	09/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the reprocessed ligasure failed.It was noticed by the physician that the hysterectomy infection that he assisted with had used a reprocessed ligasure device during the case.The complainant is not aware of any patient injury, medical intervention, or 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.It was reported the facility did not save the device.As the complaint device was not returned, a conclusive root cause could not be determined and the reported event could not be confirmed.A review of the dhr could not be performed as the lot/serial number was not reported.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: - improper handling/storage subsequent to distribution from stryker.- contamination of device in pre-op inspection.The instructions for use (ifu) state: this product cannot be adequately cleaned and/or sterilized by the user in order to facilitate safe reuse and is therefore intended for single use.Attempts to clean or sterilize these devices without appropriate regulatory authorization may result in bioincompatibility, infection, or product failure risks to the patient.Package is provided sterile by method of ethylene oxide gas.Inspect packaging for damage.If damaged, do not use.The reported event will continue to be monitored through post-market surveillance.Should the device become available for return, the investigation will be reopened.
Event or Problem Description
It was reported that the reprocessed ligasure failed.It was noticed by the physician that the hysterectomy infection that he assisted with had used a reprocessed ligasure device during the case.The complainant is not aware of any patient injury, medical intervention, or extended procedure time.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-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: 23330399
• Report Number: 0001056128-2025-00067
• Device Sequence Number: 10616395
• Product Code: NUJ
• UDI-Device Identifier: 07613327565300
• UDI-Public: 07613327565300
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K230251
• 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): 11/26/2025

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 Model Number: LF1212A
• Device Catalogue Number: LF1212A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 11/26/2025
• 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: Other
• Patient Sex: Unknown