MAUDE Adverse Event Report: MICROLINE SURGICAL INC RENEW XR HANDPIECE, 34CM (REUSABLE); REUSABLE HANDPIECE

Model Number	3941
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Arcing (2583)
Health Effect - Clinical Code	Bowel Burn (1756)
Date of Event	11/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During the procedure, the assisting surgeon discovered a monopolar burn to the bowel of the patient.The surgeons then backtracked through the procedure to check for other non-noticed burns to the patient.Surgeons reported finding 3 additional mono polar burns to the patient bowel, for a toal of 4 burns.Surgeons did not notice the burns upon immediate use of monopolar electro surgical cautery.No visualization of electrical arcing was reported at the time of incident by the surgeons or staff, however the distal portion of the renew xr handpiece demonstrates physical damage.Source of monopolar energy was recorded to be a valley lab ft10 serial number (b)(6).Settings used were cut 35 coag blend, 35 coag.
Additional Manufacturer Narrative
At this time, microline surgical is awaiting the affected device back so an investigation can be completed.Once the results of the investigation are available, a final adverse event report will be submitted.

• Brand Name: RENEW XR HANDPIECE, 34CM (REUSABLE)
• Common Device Name: REUSABLE HANDPIECE
• Manufacturer (Section D): MICROLINE SURGICAL INC; 50 dunham rd suite 1500; beverly MA 01915
• Manufacturer (Section G): MICROLINE SURGICAL INC; 50 dunham rd suite 1500; beverly MA 01915
• Manufacturer Contact: scott marchand davis ; 50 dunham rd suite 1500; beverly, MA 01915 ; 9789229810
• MDR Report Key: 20643496
• Report Number: 1223422-2024-00041
• Device Sequence Number: 12634584
• Product Code: GEI
• UDI-Device Identifier: 00811099013761
• UDI-Public: 00811099013761
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K234147
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2024

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
• Operator of Device: Health Professional
• Device Model Number: 3941
• Device Catalogue Number: 3941
• Device Lot Number: 00171665
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown