MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN IDRIVE; STAPLE, IMPLANTABLE

Model Number	INTB100
Medical Device Problem Codes	Difficult to Open or Close (2921); Premature Indicator Activation (3011)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, for the first firing in a laparoscopic sigmoidectomy procedure, they set the device and connected the cartridge with no problem.They checked the jaws opening/closing and articulation then the surgeon inserted the device to the cavity; however, the status indicator flashed green even though the green firing mode button was not touched and the jaws did not react even though the silver button was pushed.Replaced by another battery, they could remove the cartridge from the adapter.Then they connected a new cartridge to the same adapter; however, the status indicator illuminated blue and the green indicator illuminated, and the device did not react at all.Replaced by a manual handle, and the procedure was continued.The surgical time was extended by less than 30 min.The status of the patient was reported as no problem.

• Brand Name: IDRIVE
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• MDR Report Key: 7577780
• Report Number: 1219930-2018-02931
• Device Sequence Number: 19348666
• Product Code: GDW
• UDI-Device Identifier: 10884523007107
• UDI-Public: 10884523007107
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K102325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/07/2018

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
• Operator of Device: Health Professional
• Device Model Number: INTB100
• Device Catalogue Number: INTB100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization