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

Model Number	3112
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Insulation on tip came off inside patient.This was noted at the end of procedure and removed before closing.No impact to patient.
Additional Manufacturer Narrative
The returned product was cleaned, decontaminated and forwarded to quality engineering.Upon examination the shrink (insulation) tube was found to be intact, but not attached to the scissor.The shrink tube was measured and found to be at the pre-shrink size.It appears that the shrink tube was put in place, but was not subjected to the heat/shrink process.

• Brand Name: RENEW METZENBAUM SCISSOR TIP, DISPOSABLE
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENTS
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• Manufacturer (Section G): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• Manufacturer Contact: scott marchand davis ; 50 dunham road; suite 1500; beverly, MA 01915 ; 9789229810
• MDR Report Key: 12813332
• Report Number: 1223422-2021-00011
• Device Sequence Number: 4543051
• Product Code: GEI
• UDI-Device Identifier: 00811099010029
• UDI-Public: 00811099010029
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/15/2021

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: 3112
• Device Catalogue Number: 3112
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown