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

Model Number	INTB100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2018
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, during lobectomy, at the first firing, when the reload was connected to the power handle, the jaws were able to be closed, but the jaws were unable to be opened.The reload was taken out by force and a new product was used.The event occurred during the procedure, but the product was not used for patient.

• Brand Name: IDRIVE
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8094835
• Report Number: 1219930-2018-06212
• Device Sequence Number: 16641238
• 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,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2018

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: 10/29/2018
• Initial Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1