MAUDE Adverse Event Report: ETHICON ENDO SURGERY INC. HARMONIC FOCUS SHEARS; HARMONIC SHEARS

Lot Number H4LH5Y

Device Problems Other (for use when an appropriate device code cannot be identified) (2203); Failure to Cut (2587)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2016

Event Type  malfunction  

Event Description

Reported to risk that surgeon was using the device and the device would coagulate but would not cut.Device was changed out and surgery proceeded as planned without any ill effects documented from the event in the pt's record.The pt remains in the hospital recovering from their disease.

• Brand Name: HARMONIC FOCUS SHEARS
• Type of Device: HARMONIC SHEARS
• Manufacturer (Section D): ETHICON ENDO SURGERY INC.; 4545 creek road; cincinnati OH 45242
• MDR Report Key: 5825815
• MDR Text Key: 50637799
• Report Number: 5825815
• Device Sequence Number: 1
• Product Code: LFL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Lot Number: H4LH5Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/13/2016
• Distributor Facility Aware Date: 07/11/2016
• Device Age: NA
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 83 YR