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)
Date of Event	01/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.Device analysis: the analysis results found that the (b)(4) device was returned inside its package unopened.Upon visual inspection, a loose clip was observed to be inside the package.No conclusion could be reach as to what caused the clip to fall out from the device.It is possible that the package was submitted to higher forces then normal during transportation, allowing the clip to fall out from the device.It should be noted that a 100% inspections takes place during manufacturing to ensure the device meets the require specifications.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.
Event or Problem Description
It was reported that during an unknown procedure, the surgeon opened the packaging and noted that there was cartridge retention.The surgeon did not use it on the patient.There were no adverse consequences to the patient.No additional information could be provided.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 9793524
• Report Number: 3005075853-2020-01449
• Device Sequence Number: 2750739
• 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
• Report Date (Section B): 01/14/2020

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: 04/30/2022
• Device Model Number: TLH30
• Device Catalogue Number: TLH30
• Device Lot Number: P4RK1Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 03/05/2020
• Patient Sequence Number: 1