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

Model Number 3122

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/17/2020

Event Type  malfunction  

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 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
• Type of Device: MANUCAL DETACHABLE SURGICAL INSTRUMENTS
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly, ma
• Manufacturer (Section G): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly, ma
• Manufacturer Contact: scott marchand davis ; 50 dunham road; suite 1500; beverly, ma ; 9229810
• MDR Report Key: 9732214
• MDR Text Key: 195112406
• Report Number: 1223422-2020-00005
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00811099010036
• UDI-Public: 00811099010036
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K962119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1