MAUDE Adverse Event Report: MICROLINE SURGICAL INC. RENEW MICROSCISSOR TIP, DISPOSABLE; MANUCAL DETACHABLE SURGICAL INSTRUMENTS

Model Number	3122
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was retuned, decontaminated and visually inspected.Included in the investigation were, a review of the dhr and the fmea, and a manufacturing personnel's interview.This is an isolated incident and the root cause could not be identified at this time.
Event or Problem Description
During surgery, the surgeon found that the heat shrink had come off in the patient's abdominal cavity.

• Brand Name: RENEW MICROSCISSOR TIP, DISPOSABLE
• Common Device Name: MANUCAL DETACHABLE SURGICAL INSTRUMENTS
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly, ma
• MDR Report Key: 9732214
• Report Number: 1223422-2020-00005
• Device Sequence Number: 2352970
• Product Code: GEI
• UDI-Device Identifier: 00811099010036
• UDI-Public: 00811099010036
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K962119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2020

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: 07/28/2024
• Device Model Number: 3122
• Device Catalogue Number: 3122
• Device Lot Number: 00147974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1