MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC HARMONIC ACE+; INSTRUMENT, ULTRASONIC

Catalog Number HAR36

Device Problems Device Slipped (1584); Failure to Fire (2610)

Patient Problem No Information (3190)

Event Date 10/12/2014

Event Type  malfunction  

Event Description

Har36- would not fire, changed cord and worked for a little while, then generator stated to tighten device, tried multiple items to tighten and retest device with no avail.- opened new device and it worked.
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manufacturer response for harmonic shears, (brand not provided) (per site reporter).
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product in the or office, waiting on rep to check device out.

• Brand Name: HARMONIC ACE+
• Type of Device: INSTRUMENT, ULTRASONIC
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC; 4545 creek road; cincinnati, OH 45242
• MDR Report Key: 4216289
• MDR Text Key: 4976043
• Report Number: 4216289
• 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: 10/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: HAR36
• Device Lot Number: 3039064
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/16/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2014
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 169