MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS EEA; STAPLE, IMPLANTABLE

Model Number	EEAXL2835
Medical Device Problem Codes	Misfire (2532); Mechanics Altered (2984)
Health Effect - Clinical Codes	Respiratory Distress (2045); Tissue Damage (2104); No Code Available (3191)
Date of Event	03/02/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter: occurred during a robotic assisted laparoscopic left colectomy procedure.The stapler misfired while crea ting the anastomosis.The stapler cut and fired only half of the staples.During the anastomosis, the stapler was lined up and the device was engaged and completely fired.Staples did not clamp down as they should have.The procedure was converted to a lower anterior resection.The procedure was prolonged due to the misfire.There was no harm to the patient.While in the post-anesthesia care unit (pacu), the patient became apneic, requiring bipap and narcan.The patient's respiratory issues had resolved prior to being transferred to the intensive care unit (icu).Due to the prolonged surgery time and the patient's chronic obstructive pulmonary disease (copd), the patient required more treatment after surgery.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: the donuts were fully formed.There were two complete rings of tissue.The stapler cut but the staples themselves did not engage.The procedure was converted to a robotic lower anterior resection.There was some tissue loss to re-do the anastomosis and resect additional rectum and colon.There was no blood loss over 500 cc.The procedure was prolonged by about sixty minutes due to the misfire.The current status of the patient is fine and recovered per usual course.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis summary: post market vigilance (pmv) received one device.The visual inspection of the staple guide noted the instrument was fully applied.Further inspection noted that the green bar was not visible in the indicator window and the safety feature was not engaged.The staple guide was observed to be attached to the instrument with no damage to the staple guide.After actuating the handle, the pusher fingers appeared to be intact and inspection under the microscope displayed nicks on the knife blade.The anvil of the instrument was observed to be tilted and separated from the instrument.Further inspection of the anvil cutting ring showed shallow traces of knife impression and the ring was received partially severed.Forwarded to ponce engineering for further evaluation of staple deployment.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Microscopic examination noted nicks on the knife blade.A second partial knife impression was noted very close to the knife¿s internal diameter (id).Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the observed knife blade damage may occur if the instrument is applied over an obstruction.As part of the evaluation a shell/ anvil size mismatch firing simulation was performed and it was noticed that results from firing an instrument upon an anvil head are pretty consistent with the conditions observed in the returned anvil assembly.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EEA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• MDR Report Key: 6498031
• Report Number: 3006451981-2017-05141
• Device Sequence Number: 606305
• Product Code: GDW
• UDI-Device Identifier: 20884523006145
• UDI-Public: 20884523006145
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/23/2018

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 Expiration Date: 07/31/2021
• Device Model Number: EEAXL2835
• Device Catalogue Number: EEAXL2835
• Device Lot Number: P6G0739KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 04/27/2017; 11/29/2017; 01/04/2018
• Initial Report FDA Received Date: 04/17/2017
• Supplement Report FDA Received Date: 04/27/2017; 09/07/2017; 12/21/2017; 01/23/2018
• 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: Other; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 72