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

Model Number	INTB100
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2018
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 a bariatric surgery, while performing the gastric bypass, the load caught and did not fire.The reload was replaced by another and ran smoothly.No patient injury.

• 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: 8019728
• Report Number: 1219930-2018-05755
• Device Sequence Number: 19191145
• Product Code: GDW
• UDI-Device Identifier: 10884523007107
• UDI-Public: 10884523007107
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K102325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2018

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: 10/04/2018
• Initial Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 108