MAUDE Adverse Event Report: MICROLINE SURGICAL INC RENEW MICROSCISSOR TIP, DISPOSABLE; FLEXIBLE ENDOSCOPIC SCISSORS, SINGLE-USE

Model Number	3122
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, microline surgical, inc is awaiting the affected tip back from the importer/distributor.An investigation will be conducted, and a final adverse event report will be submitted with the results.
Event or Problem Description
The heat shrink came off during the surgery.The heat shrink was removed from the abdominal cavity, so there was no health problem.As the exact same phenomenon took place with the same lot, our customer stopped using the lot and returned to us.

• Brand Name: RENEW MICROSCISSOR TIP, DISPOSABLE
• Common Device Name: FLEXIBLE ENDOSCOPIC SCISSORS, SINGLE-USE
• 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: 20522575
• Report Number: 1223422-2024-00039
• Device Sequence Number: 9117570
• Product Code: GEI
• UDI-Device Identifier: 00811099010036
• UDI-Public: 00811099010036
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2024

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: Health Professional
• Device Model Number: 3122
• Device Catalogue Number: 3122
• Device Lot Number: 00172110
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 10/24/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown