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

Model Number	INTB100
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2019
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, after resecting the colon in a colectomy end to side anastomosis procedure, the cartridge was released from the tissue.When the nurse tried to return the cartridge to neutral position, the cartridge did not straighten.The indicator for the handle flashed green.The indicators for the adapter and the cartridge were illuminating.The status indicator flashed blue.After changing the battery, the cartridge moved as usual and was able to be disconnected, so the procedure was continued without taking further measures.The surgical time was extended by less than 30 min.There was 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: 8700469
• Report Number: 1219930-2019-03470
• Device Sequence Number: 19451045
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2019

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: 05/22/2019
• Initial Report FDA Received Date: 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1