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

Model Number	3152
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was decontaminated and forwarded to quality engineering for evaluation the scissor and the detached shrink tubing were returned for examination the scissor assembly was missing the shrink tubing.The scissor has no visual damage except for the shrink tube that was not attached.The scissors were tested using a known good hand piece.The scissor functioned correctly.The shrink tube was damaged a split (length wise).The distal edge of the shrink tube shows signs of being rolled and cut.This appearance of the damage indicates that the shrink tube was cut by impact with a rigid object.
Event or Problem Description
During a procedure, our customer found that the part which should be adhered came off.The surgeon immediately picked it up thus there was neither health damage nor extension of the procedure.A spare instrument was used to continue the procedure.

• Brand Name: RENEW MINI 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: 12542613
• Report Number: 1223422-2021-00007
• Device Sequence Number: 13738165
• Product Code: GEI
• UDI-Device Identifier: 00811099010012
• UDI-Public: 00811099010012
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2021

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 Expiration Date: 05/28/2026
• Device Model Number: 3152
• Device Catalogue Number: 3152
• Device Lot Number: 00157004
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1