MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RL LINEAR STAPLER; STAPLE, IMPLANTABLE

Catalog Number	TX30B
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: (b)(6) 2019.Batch#: t5al29.Additional information received: just for clarification, the issue with the device occurred after the surgical procedure was converted from an exploratory laparoscopy to a laparotomy correct? when the staple line showed questionable integrity, were there staples missing from the staple line? or were staples not completely formed in a b-form shape (malformed)? i was not present during the case, and was not provided with that information.It was only reported that the staples showed questionable integrity.Investigation summary: the analysis results showed that the tx30b device arrived with no apparent damage and with no reload present.The device was tested for functionality with a test reload and it fired and formed all the staples as intended.The device fired without any difficulties, the staples were noted to have a proper b-formation and the staple line was complete.Event could not be confirmed as no cartridge was returned for analysis.This report is not intended to deny that a problem was experienced with the device.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.
Event or Problem Description
It was reported that during an exploratory laparoscopy converted to a laparotomy, it was stated that once converted they recognized the bowel had perforated, so they used the stapler to close the perforation.The staple line showed questionable integrity so the surgeon oversewed the staple line to successfully complete the procedure.There were no patient consequences.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8879244
• Report Number: 3005075853-2019-21129
• Device Sequence Number: 2447706
• Product Code: GDW
• UDI-Device Identifier: 10705036003311
• UDI-Public: 10705036003311
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/18/2019

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: 01/28/2024
• Device Catalogue Number: TX30B
• Device Lot Number: T40716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1