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)
Date of Event	03/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.
Event or Problem Description
It was reported that during an open pd, ¿two switch activations detected¿ was displayed when the max button was pressed.And the device was activated automatically though no button was pressed.The min button functioned properly.The device was used on the blood vessels.The blade tip was not broken off and no pieces fell into the patient.Gen11 was used.Another device was used to complete the case.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Batch # p91r4c.Investigation summary: the device was returned with no apparent damage.The device was tested on generator and it was found that the max and min hand control switch assembly buttons were not functional.However, it worked properly with foot switch assembly.The device was disassembled to inspect internal components.During analysis, moisture was discovered in the instrument.Since we are unable to determine how this condition impacted the performance of the device, we cannot determine root cause of the issue associated with this inquiry.Our manufacturing, sterilization, packaging, and shipment processes do not introduce corrosion and/or moisture to the device; the moisture may be evidence of reuse or reprocessing.It is possible that moisture under the dome could have resulted in an error screen of ¿reactivate two switch activations detected¿.In addition this also could have resulted in continuous activation.However, this was not seen during analysis.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: 7355970
• Report Number: 3005075853-2018-08657
• Device Sequence Number: 16406943
• 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): 03/06/2018

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: 02/28/2022
• Device Catalogue Number: FCS17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1