MAUDE Adverse Event Report: MICROLINE SURGICAL RENEW ENDOCUT SCISSOR TP, DISPOSABLE; MANUAL DETACHABLE SURGICAL INSTRUMENT

Model Number	3142
Medical Device Problem Codes	Use of Device Problem (1670); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A white silicone band was inadvertently left on the device tip and subsequently dislodged into the patient's chest cavity during the initial procedure on (b)(6) 2025.The surgeon closed the chest without noticing the band.During a subsequent reoperation for an unrelated reason on (b)(6) 2025, the silicone band was discovered and removed.The silicon band was removed safely.
Additional Manufacturer Narrative
At this time, microline surgical, inc.Is awaiting the return of the affected device from the hospital in order to conduct a full investigation.A final report will be submitted once the investigation is complete and additional information becomes available.
Event or Problem Description
A white silicone band was inadvertently left on the device tip and subsequently dislodged into the patient's chest cavity during the initial procedure on (b)(6) 2025.The surgeon closed the chest without noticing the band.During a subsequent reoperation for an unrelated reason on (b)(6) 2025, the silicone band was discovered and removed.The silicon band was removed safely.
Additional Manufacturer Narrative
The associated product was not returned to msi for investigation.

• Brand Name: RENEW ENDOCUT SCISSOR TP, DISPOSABLE
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENT
• Manufacturer (Section D): MICROLINE SURGICAL; 50 dunham rd; suite 1500; beverly MA 01915
• Manufacturer (Section G): MICROLINE SURGICAL; 50 dunham rd; suite 1500; beverly MA 01915
• Manufacturer Contact: scott marchand davis ; 50 dunham rd suite 1500; beverly, ma, MA 01915 ; 9789229810
• MDR Report Key: 22690324
• Report Number: 1223422-2025-00024
• Device Sequence Number: 20895785
• Product Code: GEI
• UDI-Device Identifier: 00811099010005
• UDI-Public: 00811099010005
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213127
• 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,Followup
• Report Date (Section B): 08/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 3142
• Device Catalogue Number: 3142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 09/05/2025
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown