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

Model Number	TA6035L
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2019
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 an open hepatectomy procedure, when the device was being applied to the jejunum, the surgeon performed full, complete squeezes of the handle but the device not able to fire.A new device was used to complete the case.No injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.A 3.5mm single use loading unit (sulu) was received.Visual inspection of the sulu cartridge noted that a full staple complement was present.The clinical instrument was received.Functionally, the instrument and sulu were applied to test media with proper staple formation.Although the reported condition was not confirmed, it may occur when the user mistakes the tactile pre-clamp feature for the full firing stroke.This feature allows the handle to be released, without returning to its original position, for final positioning of the tissue.After the tissue is properly positioned, the handle stroke must be continued to full clamp position.Staples will only fire after the fully clamped handle returns to its original position and is squeezed a second time.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.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: 8565559
• Report Number: 2647580-2019-02338
• Device Sequence Number: 2349204
• Product Code: GDW
• UDI-Device Identifier: 20884521043203
• UDI-Public: 20884521043203
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 07/16/2019

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: 02/28/2021
• Device Model Number: TA6035L
• Device Catalogue Number: TA6035L
• Device Lot Number: P6B0657X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1