MAUDE Adverse Event Report: ETHICON ENDO-SURGERY INC. ETHICON INSTRUMENT

Lot Number 3919035

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2015

Event Type  malfunction  

Event Description

After closing the device 3 times to use it, the device would no longer close.No harm to pt.

• Brand Name: ETHICON INSTRUMENT
• Type of Device: ETHICON INSTRUMENT
• Manufacturer (Section D): ETHICON ENDO-SURGERY INC.; cincinnati OH 45242
• MDR Report Key: 5690707
• MDR Text Key: 46365242
• Report Number: MW5062540
• Device Sequence Number: 1
• Product Code: GEI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2016
• Device Lot Number: 3919035
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR