MAUDE Adverse Event Report: US SURGICAL PUERTO RICO TA; STAPLE, IMPLANTABLE

Model Number	TA9035L
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Codes	Tissue Damage (2104); No Code Available (3191)
Date of Event	07/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, when the stapler was being fired across the large colon on an open bowel resection, a 3.5mm reload was used with a 4.8mm handle but staples did not deploy on the first firing.The tissue was cut thinking that the staples were deployed.Another 3.5mm reload was used on the same handle but did not deploy staples either.Clamps were put across the open wound to temporarily close the opening and the stapler was reloaded with another reload.The surgeon removed the clamps and fired the stapler across the bowel.This time, the surgeon did not cut any extraneous tissue off before opening the stapler.The surgeon opened another 4.8mm handle and another 3.5mm reload and everything worked fine.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the single use loading unit(sulu) noted that all of the staples were partially advanced in the cartridge.The staples were in unusable unformed condition.Functionally, the sulu was reloaded with staples.The instrument and sulu were applied to test media with proper staple formation.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 advanced staple condition may occur when the firing stroke is not completed during application.The instructions for use of this product state: to fire the instrument, squeeze the handle a second time until it reaches a solid stop and it locks in the back position.If the instrument handle is partially squeezed during firing then released, bleeding may occur as the instrument was not fully fired.The current packaging design for the product does not allow room for advanced staples, thus the condition could not have occurred during assembly or shipment.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: TA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 8872127
• Report Number: 2647580-2019-04039
• Device Sequence Number: 13910544
• Product Code: GDW
• UDI-Device Identifier: 10884521043244
• UDI-Public: 10884521043244
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2019

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 Model Number: TA9035L
• Device Catalogue Number: TA9035L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 10/04/2019
• 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