MAUDE Adverse Event Report: MICROLINE SURGICAL INC. VISU-LOC 5MM MULTI-FIRE SPRING CLIP APPLIER, 20 CLIPS, DISPOSABLE; IMPLANTABLE CLIP

Model Number	2001
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to microline surgical for an investigation.No further information is available at this time.
Event or Problem Description
Clip applier jammed during procedure.Anesthesia time was extended 5 minutes.There was no harm to the patient.

• Brand Name: VISU-LOC 5MM MULTI-FIRE SPRING CLIP APPLIER, 20 CLIPS, DISPOSABLE
• Common Device Name: IMPLANTABLE CLIP
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• MDR Report Key: 8784354
• Report Number: 1223422-2019-00018
• Device Sequence Number: 11185034
• Product Code: FZP
• UDI-Device Identifier: 00811099010418
• UDI-Public: 00811099010418
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K033161
• 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): 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2020
• Device Model Number: 2001
• Device Catalogue Number: 2001
• Device Lot Number: 00137790
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1