MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC.; INSTRUMENT, ULTRASONIC SURGICAL

Model Number M9206N

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 07/22/2016

Event Type  malfunction  

Event Description

Prior to introduction into the abdominal cavity, the tip became loose and fell off the device.

• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; 4545 creek rd.; cincinnati, OH 45242
• MDR Report Key: 5871353
• MDR Text Key: 51995910
• Report Number: 5871353
• 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: 07/22/2016

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 Model Number: M9206N
• Device Catalogue Number: HARH36
• Device Lot Number: N90681
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2016
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2016
• 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: 27 YR