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

Model Number 3142

Device Problem Insufficient Information (3190)

Patient Problems Internal Organ Perforation (1987); Superficial (First Degree) Burn (2685)

Event Date 03/29/2024

Event Type  Injury  

Event 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).

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
• Type of Device: 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
• MDR Text Key: 339912237
• Report Number: 1223422-2024-00010
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00811099010005
• UDI-Public: 00811099010005
• Combination Product (y/n): N
• PMA/PMN Number: K213127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3142
• Device Catalogue Number: 3142
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention