MAUDE Adverse Event Report: MICROLINE SURGICAL INC. RENEW ENDOCUT SCISSOR TIP, DISPOSABLE; MANUAL DETACHABLE SURGICAL INSTRUMENTS

Model Number	3142
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was decontaminated and forwarded to quality engineering for evaluation.The scissor tip assembly, and what appears to be a torn shrink tubing was returned for review, the scissor tip was visually examined, no obvious damage was noted with the exception of the shrink tubing not attached.The tip was installed on a known good hand piece and was cycled open and closed.The device functioned without binding and was able to fully open and close.The shrink tube was examined under magnification.The section examined was cleanly cut, which would indicate that the shrink tube may have been in contact with a sharp object.The source of the contact was not determined.The scissor tips are subject to 100% cut testing and visual inspection prior to shipment.
Event or Problem Description
During a lap chole the black plastic (heat shrink) on a disposable scissor tip came apart and had to be retrieved from the patient's abdomen.There was no harm to the patient.

• Brand Name: RENEW ENDOCUT SCISSOR TIP, DISPOSABLE
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENTS
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• MDR Report Key: 12420575
• Report Number: 1223422-2021-00006
• Device Sequence Number: 3609659
• Product Code: GEI
• UDI-Device Identifier: 00811099010005
• UDI-Public: 00811099010005
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K962119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2021

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: 3142
• Device Catalogue Number: 3142
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1