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

Model Number	EEAORVIL25
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: health professional (hpro).(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during laparoscopic gastric bypass, on creating gastrojejunostomy, the surgeon stated that the anvil pulled out of the gastrotomy when they attempted to mate the anvil and trocar or spike.The device did not fire due to the instrument issue.The surgeon alleges that the anvil never flipped up from its original tilted position and thus was pulled through the gastric pouch with ordinary effort.The surgery was extended by roughly one hour per the surgeon¿s statement.They attributed this to using the device in every case and being out of practice with a ¿po¿ ear stapled anastomosis for the gastrojejunostomy.The surgeon completed the case by using linear endostaplers to create a side-to-side anastomosis.
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 laparoscopic gastric bypass, on creating gastrojejunostomy, the surgeon stated that the anvil pulled out of the gastrotomy when they attempted to mate the anvil and trocar or spike before green bar was visible.The device did not close enough to show the green bar.The device did not fire due to the instrument issue.Use was aborted due to the anvil being displaced and no fire was attempted.The surgeon alleges that the anvil never flipped up from its original tilted position and thus was pulled through the gastric pouch with ordinary effort.The surgery was extended by roughly one hour per the surgeon¿s statement.They attributed this to using the device in every case and being out of practice with a ¿po¿ ear stapled anastomosis for the gastrojejunostomy.The surgeon completed the case by using linear endostaplers to create a side-to-side anastomosis.

• Brand Name: EEA ORVIL
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7809203
• Report Number: 1219930-2018-04626
• Device Sequence Number: 1469113
• Product Code: GDW
• UDI-Device Identifier: 20884521042862
• UDI-Public: 20884521042862
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K062850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EEAORVIL25
• Device Catalogue Number: EEAORVIL25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 09/12/2018
• 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: Required Intervention