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

Model Number	030450
Medical Device Problem Codes	Break (1069); Component or Accessory Incompatibility (2897)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2020
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 laparoscopic living donor nephrectomy, when an attempt was made to attach the cartridge to the handle, the plastic for fixing on the connection part broke, so the cartridge seemed unable to be connected properly.When a new cartridge was connected, no issue occurred.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 one device.Visual examination of the staple cartridge noted that the loading unit had a full complement of staples.The lock ring was observed to be broken.Testing of the loading unit could not be performed due to the noted damages.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 damaged loading unit lock ring may occur due improper orientation of the lock ring or over flexure of the loading unit while attached to the instrument.The root cause of the observed damage was found to be due to the device not being used as intended 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: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 9663801
• Report Number: 1219930-2020-00579
• Device Sequence Number: 2800588
• Product Code: GDW
• UDI-Device Identifier: 10884523002812
• UDI-Public: 10884523002812
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2020

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 Model Number: 030450
• Device Catalogue Number: 030450
• Device Lot Number: T8K108X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1