MAUDE Adverse Event Report: ETHICON 4545 CREEK ROAD ACE + 7 LAPAROSCOPIC HARMONIC SHEARS

Lot Number N93H8Y

Device Problems Material Separation (1562); Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2017

Event Type  malfunction  

Event Description

An (b)(6) female came to the hospital to have a repair of a paraesophageal hernia.She had a laparoscopic paraesophageal hernia repair with mesh.It was reported to risk that during surgery with the use of the harmonic shears that they malfunctioned with the white plastic ridged coating of the device coming off part of the device tip.The surgeon made sure the patient tissue was not injured and a second harmonic scalpel was then opened and used without incident.The patient was discharged home the following day.Device available for ethicon representative to come to risk office to pick up product.

• Brand Name: ACE + 7 LAPAROSCOPIC HARMONIC SHEARS
• Type of Device: HARMONIC SHEARS
• Manufacturer (Section D): ETHICON 4545 CREEK ROAD; cincinnati OH 45242
• MDR Report Key: 6435603
• MDR Text Key: 71174542
• Report Number: 6435603
• 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: 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Lot Number: N93H8Y
• 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: 03/06/2017
• Distributor Facility Aware Date: 02/28/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2017
• 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: 81 YR