MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RL TITAN HEAVY WIRE; STAPLE, IMPLANTABLE

Model Number	TLH30
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date of event: unknown.Batch # unknown.Per photographic evaluation: upon visual inspection of one photo, the following was observed: the photo shows a linear stapler from top view with no reload loaded.The reload can be seen near of device.The safety disengaged.Based on the photo reviewed, the event describe cannot be confirmed.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.
Event or Problem Description
It was reported that during a pneumonectomy procedure, the staples were not deployed at the firing on the bronchial tube.It was found that the staples were scattered on the mayo table.There was no bleeding and leakage for the patient.The surgeon sutured the staple line.Another device was used to complete the case.There were no adverse consequences to the patient.The patient is stable.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 02/12/2020.D4: batch # r57r5y.Device analysis: the analysis results showed that the tlh30 device arrived with no apparent damage with a reload loaded on the device.The reload was returned fully loaded with staples.The device was tested for functionality with the returned reload and it cycled, fired, and all the staples formed as intended.The staple line was complete, and the staples meet the staple form release criteria.The event described could not be confirmed as the device performed without any difficulties noted.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9581084
• Report Number: 3005075853-2020-00265
• Device Sequence Number: 14288159
• Product Code: GDW
• UDI-Device Identifier: 10705036013228
• UDI-Public: 10705036013228
• Combination Product (Y/N): N
• 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): 12/17/2019

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: 02/09/2023
• Device Model Number: TLH30
• Device Catalogue Number: TLH30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 02/12/2020
• Patient Sequence Number: 1