MAUDE Adverse Event Report: MICROLINE SURGICAL INC. RENEW HANDPIECE, 34CM, REUSABLE; MANUAL DETACHABLE SURGICAL INSTRUMENTS

Model Number	3904
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to microline surgical, inc.No investigation can be performed at this time.
Event or Problem Description
During a procedure the o-ring broke off the handpiece and fell into patient abdomen; all pieces were retrieved.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 a damage o-ring.The device was returned with a small portion of the o-ring showing from the distal end of the hand piece.About 90% of the o-ring that is meant to be showing and attached to the device was missing.The remaining 10% of the o-ring looked extremely worn and torn.The device looks like it has been miss handle and insufficiently maintained.The ifu provides information on the precautions and warnings to lower the risk of damaging the o-ring.This is a know issue that is currently being addressed in capa: 170004.Although this is a know issue, if the proper precautionary steps that are listed in the ifu were being followed, it would be close to impossible for the device to fail in this manner.Below are the specific steps that would have prevented this failure from occur doing an operation.Handpiece/tip assembly: 3."hold the jaws and turn the hand piece rotation knob clockwise until tip is screwed tight." precautions: 2.Caution: prior to use, assure that plastic hub of tip is fully in contact with the insulation tube of hand piece and that no gap exists between the two parts at that contact point.3.Do not use hand piece if "o" ring located on distal end of shaft appears worn, damaged or missing.This complaint is confirmed.A possible root cause is due to user error.
Event or Problem Description
During a procedure the o-ring broke off the handpiece and fell into patient abdomen; all pieces were retrieved.There was no harm to the patient.

• Brand Name: RENEW HANDPIECE, 34CM, REUSABLE
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENTS
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• MDR Report Key: 8883659
• Report Number: 1223422-2019-00023
• Device Sequence Number: 19515677
• Product Code: GEI
• UDI-Device Identifier: 00811099010548
• UDI-Public: 00811099010548
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K962119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2019

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: 3904
• Device Catalogue Number: 3904
• Device Lot Number: 00128742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 08/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1