MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN LP LLC - MFG PREMIUM MULTIFIRE TA; APPARATUS, SUTURING, STOMACH AND INTESTINAL

Model Number	010315
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Tissue Damage (2104); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	05/09/2018
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 left pneumonectomy, while they used the device on the superior pulmonary vein without any problem, they proceeded to apply the instrument on the second left pulmonary vein & activated the instrument.When they wanted to open it, the instrument remained close on the vein.They had to dissect the vein toward the mediastinum to apply a new instrument without any problem.They were the able to take the instrument out of the patient.The procedure was completed without any problem after that.The instrument being returned will be in the close position with the vein segment in it.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The instrument was received fully applied.The jaw was open, tissue was observed in the jaw with a full complement of staples present.Functionally; the device loading unit(dlu) was reset.The jaw closes smoothly.The pin slide advances fully.The jaw opens when open button is depressed.The instrument and dlu were cycled with acceptable results.No functional abnormalities were observed.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a left pneumonectomy, while they used the device on the superior pulmonary vein without any problem, they proceeded to apply the instrument on the second left pulmonary vein <(>&<)> activated the instrument.When they wanted to open it, the instrument remained close on the vein.They had to dissect the vein toward the mediastinum to apply a new instrument without any problem.They were the able to take the instrument out of the patient.The procedure was completed without any problem after that.The instrument being returned will be in the close position with the vein segment in it.There was no patient injury.

• Brand Name: PREMIUM MULTIFIRE TA
• Common Device Name: APPARATUS, SUTURING, STOMACH AND INTESTINAL
• Manufacturer (Section D): COVIDIEN NORTH HAVEN LP LLC - MFG; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7522212
• Report Number: 1219930-2018-02695
• Device Sequence Number: 1386000
• Product Code: FHM
• UDI-Device Identifier: 10884521045965
• UDI-Public: 10884521045965
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K801589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2018

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: 10/31/2018
• Device Model Number: 010315
• Device Catalogue Number: 010315
• Device Lot Number: N3K0205X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 08/10/2018
• 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: 44 YR
• Patient Weight: 83