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

Model Number	4901T
Medical Device Problem Codes	Fluid/Blood Leak (1250); Failure to Form Staple (2579)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: health professional (hpro).(surgical intervention).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: during the closure of an open esophagectomy, there had been a leakage.The device has not been stapled correctly.To resolve the issue, lavage was performed, a stent was inserted at the revision operation, and the leakage was over sewn.The surgical time was extended to more than 30 minutes and the patient hospitalization was prolonged.An additional operation was also performed.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The instrument was received loaded with a 4.8mm single use loading unit (sulu).Visual inspection of the cartridge noted that the sulu was fully fired.The loading unit was reloaded with staples, reloaded into the instrument and applied to test media.The staple line was properly formed.A review of the device history record indicates the product was released meeting all quality release specifications.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PI
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7829131
• Report Number: 1219930-2018-04750
• Device Sequence Number: 11347057
• Product Code: GDW
• UDI-Device Identifier: 10884521066519
• UDI-Public: 10884521066519
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K911252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2018

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: 02/28/2023
• Device Model Number: 4901T
• Device Catalogue Number: 4901T
• Device Lot Number: N8B0228X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 10/09/2018
• 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
• Patient Age: 82 YR