MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HS ACE 14 CM SCISSOR HANDLE; INSTRUMENT, ULTRASONIC SURGICAL

Model Number	ACE14S
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4); batch #: unk.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.
Event or Problem Description
It was reported that during an unknown procedure, the surgeon found the tip broken after use.No further information is available.No patient consequence reported.

• Brand Name: HS ACE 14 CM SCISSOR HANDLE
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 10843072
• Report Number: 3005075853-2020-06011
• Device Sequence Number: 3732783
• Product Code: LFL
• UDI-Device Identifier: 10705036000884
• UDI-Public: 10705036000884
• Combination Product (Y/N): N
• PMA/510(K) Number: K051036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/21/2017

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: ACE14S
• Device Catalogue Number: ACE14S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2017
• Initial Report FDA Received Date: 11/16/2020
• Patient Sequence Number: 1