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

Catalog Number	XR30G
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.Additional information was requested and the following was obtained: can you please clarify what is meant by "while the lobectomy surgery, xr30g did not close the bronchus tissue "? did the device lock out and could not be fired at all? or was the trigger advanced with no staples deployed? were there missing staples from the staple line? if the device deployed staples, what was the appearance of the staples (b-formation, irregular, legs straight)? how was the procedure completed? were there any patient consequences? response: the device deployed staple.It did not lock out.Lobectomy procedure completed with ec60a instead of xr30g.So, there was no any patient consequences.Further information was requested and the following was obtained: thank you for the additional information you provided.Can you please further clarify how the "bronchus tissue was not closed" as you have stated, "the device deployed staple.It did not lock out." were the staples that did deploy in b-formation? or were there unformed or malformed staples seen? was the staple line complete? or were there staples missing from the staple line? response: the device deployed staple.So; bronchus tissue was not closed.Staple line was not completed this device.Instead of xr30g, they completed the surgery via echelon60.The surgeon said that he didn't pay attention to the b formation, because the device didn't close the tissue, he immediately continued the case with echelon device.
Event or Problem Description
It was reported that while the lobectomy surgery, xr30g did not close the bronchus tissue.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Batch # l54y5v.Device evaluation summary: the analysis results showed that the xr30g cartridge was received with no apparent damage.The reload was returned void of staples.No functional test was performed due the condition of the cartridge.Event described could not be confirmed as the cartridge was received fully fired.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8245242
• Report Number: 3005075853-2019-15902
• Device Sequence Number: 16691870
• Product Code: GDW
• UDI-Device Identifier: 10705036013440
• UDI-Public: 10705036013440
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2018

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: 09/22/2019
• Device Catalogue Number: XR30G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1