MAUDE Adverse Event Report: ETHICON ENDO-SURGERY LLC HARMONIC ACE LAPAROSCOPIC SHEARS; ENDOSCOPIC CUTTING COAG

Catalog Number HAR36

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2016

Event Type  malfunction  

Event Description

During a laparoscopic resection of a hepatic mass, it was determined that the disposable harmonic laparoscopic shears being used had a loose piece on the inside of the upper jaw.The surgeon deemed it not to be safe to use.It was replaced by other equipment and the patient was not harmed.

• Brand Name: HARMONIC ACE LAPAROSCOPIC SHEARS
• Type of Device: ENDOSCOPIC CUTTING COAG
• Manufacturer (Section D): ETHICON ENDO-SURGERY LLC; 4545 creek rd.; cincinnati OH 45242
• MDR Report Key: 5684631
• MDR Text Key: 46093387
• Report Number: 5684631
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/17/2016

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
• Device Operator: Physician
• Device Expiration Date: 09/01/2020
• Device Catalogue Number: HAR36
• Device Lot Number: M9317T
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/17/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR