MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN EEA; GUIDE, SURGICAL, INSTRUMENT

Model Number	EEATAID25D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product is not sold in us and is 510(k) exempt.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during laparoscopic roux-en-y gastric bypass, when the surgeon applied the introducer onto the stapler and as the device was introduced into the abdominal cavity of the patient the introducer broke in half.Another introducer was tried to use but it broke as well.The surgeon then opened a new stapler and inserted it without using introducer and the case was completed without problem.There was no patient injury.
Additional Manufacturer Narrative
Additional information: d10, g4, h3, h6 h3 evaluation summary: post market vigilance (pmv) led an evaluation of two devices.Visual inspection noted that the introducers were observed to be broken at grasping notches.The suture loops were attached to the tip of the introducers.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 condition may occur if excessive force is used to insert the instrument with the introducer.The root cause of the observed damage was due to the product not being used as indicated which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EEA
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 9519423
• Report Number: 1219930-2019-07144
• Device Sequence Number: 10885546
• Product Code: FZX
• UDI-Device Identifier: 20884521045719
• UDI-Public: 20884521045719
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2020

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 Expiration Date: 07/31/2020
• Device Model Number: EEATAID25D
• Device Catalogue Number: EEATAID25D
• Device Lot Number: K5G0002X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR