MAUDE Adverse Event Report: MICROLINE SURGICAL INC RENEW ENDOCUT SCISSORS, DISPOSABLE; MANUAL DETACHABLE SURGICAL INSTRUMENT

Model Number	3142
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Internal Organ Perforation (1987); Superficial (First Degree) Burn (2685)
Date of Event	03/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during a lap removal of adnexal/ovary, a non-medtronic device was being used with the generator and cord.At the point where the microline disposable attached to the instrument melted which caused a burn and perforation of the uterus.When instrument was removed everything appeared to be connected properly.The perforation was sutured and additional hospital stay was not required.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
Additional Manufacturer Narrative
This event was intially reported to the fda by the facility where the event occured and it was given the report number mw5153458 in the fda maude database.The initial reporter has requested to remain anonymous, so it is unclear where this event occured and no requests for the device back can be done.No investigation could be conducted as the product was never returned to msi, and it is not expected to be returned.

• Brand Name: RENEW ENDOCUT SCISSORS, DISPOSABLE
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENT
• 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: 19087564
• Report Number: 1223422-2024-00010
• Device Sequence Number: 15258042
• Product Code: GEI
• UDI-Device Identifier: 00811099010005
• UDI-Public: 00811099010005
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/11/2024

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: 3142
• Device Catalogue Number: 3142
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Seven-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 04/11/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown