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

Model Number	TA4548L
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2018
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 an anterior resection, the device did not fire.They replaced with another device to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the 4.8mm single use loading unit (sulu) cartridge noted that a full staple complement was present.Since the instrument was not returned a representative instrument was used for testing.Functionally, the representative 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.Our investigation was unable to determine a root cause or establish a relationship between the device and the reported.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: 7838959
• Report Number: 2647580-2018-04361
• Device Sequence Number: 1809046
• Product Code: GDW
• UDI-Device Identifier: 10884521043183
• UDI-Public: 10884521043183
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2018

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 Model Number: TA4548L
• Device Catalogue Number: TA4548L
• Device Lot Number: TA4548L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1