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

Model Number	3914
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer.Therefore, no investigation can be performed at this time.If the product is returned, and investigation will be performed and a follow-up report will be submitted.
Event or Problem Description
The device was used during an appendectomy by the surgeon.The handle grip was stiff to unlock and nearly caused vessel damage while unlocking.The procedure was extended for an unknown amount of time.

• Brand Name: RENEW RATCHETED 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: 9125877
• Report Number: 1223422-2019-00025
• Device Sequence Number: 19538022
• Product Code: GEI
• UDI-Device Identifier: 00811099010579
• UDI-Public: 00811099010579
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K962119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2019

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: 3914
• Device Catalogue Number: 3914
• Device Lot Number: 00144716
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR