MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HS FOCUS 17 CM CURVED SHEAR; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	FCS17
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # j9130v.The batch history records were reviewed and the manufacturing criteria were met prior to the release of this batch.
Event or Problem Description
It was reported that during an unknown procedure, the device was activated automatically though neither foot switch nor hand switch was pressed.The blade tip was not broken off and no pieces fell into the patient.Another device was used to complete the case.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Batch # j9130v.Investigation summary: the device was returned with no apparent damage.The device was connected to a test hand piece and a gen11, during functional testing it was noted that the hand control buttons were nonfunctional.However, the device did activate when tested with the foot switch.The device was disassembled to inspect the internal components.Corrosion was found at the hand activation domes.The corrosion in the domes is possibly caused when the device was soaked for cleaning before shipment for analysis.Due to the moisture discovered on the instrument, we are unable to determine how this condition impacted the performance of the device and therefore cannot conclude root cause.Our manufacturing, sterilization, packaging, and shipment processes do not introduce corrosion / moisture to the device.It is possible that due to the moisture found inside of the dome could have resulted in the continuous activation issues reported.The batch history record was reviewed and no defects, nc¿s or protocols related to the complaint, were found during the manufacturing process.

• Brand Name: HS FOCUS 17 CM CURVED SHEAR
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7101966
• Report Number: 3005075853-2017-06595
• Device Sequence Number: 19197924
• Product Code: LFL
• UDI-Device Identifier: 20705036001949
• UDI-Public: 20705036001949
• Combination Product (Y/N): N
• PMA/510(K) Number: K063192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2017

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 Expiration Date: 04/30/2017
• Device Catalogue Number: FCS17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2017
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 12/08/2017
• Supplement Report FDA Received Date: 01/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1