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

Model Number	3252
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been returned to microline surgical, inc.Once the device is returned, an investigation will be performed.
Event or Problem Description
A piece of the tip broke during a procedure.There was no harm to the patient.
Additional Manufacturer Narrative
The device was returned, decontaminated, and visually investigated.Upon visual investigation, this complaint is confirmed.The device was returned with and extremely torn and damaged heat shrink.
Event or Problem Description
A piece of the tip broke during a procedure.There was no harm to the patient.

• Brand Name: RENEW LAPCLINCH GRASPER 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: 8363441
• Report Number: 1223422-2019-00004
• Device Sequence Number: 2035597
• Product Code: GEI
• UDI-Device Identifier: 00811099010074
• UDI-Public: 00811099010074
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K981389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

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: 3252
• Device Catalogue Number: 3252
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1