MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC.; STAPLE, IMPLANTABLE

Catalog Number SC60

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should the information be provided later, a supplemental medwatch will be sent.Batch # l54l2g.Additional information requested but unavailable: what was meant by ¿device was defective¿? did the device deliver any staples? if yes, were the staples formed properly? if yes, was the staple line complete? did the device cut? if yes, was the cut line complete? on which firing(s) did this event occur (1st, 2nd, 12th, etc.)? what color cartridge was being used? was buttressing material utilized? if so, which product? were any unexpected noises heard? if so, when? were any of the forces higher or lower than expected (closing or opening)? can you please send the completed complaint form? the analysis results found that one sc60 device was returned in good visual condition and with no cartridge reload present.The device was noted to have the firing mechanism damaged.No functional test could be performed due to the condition of the device.The device was disassembled to verify the condition of the internal components and the firing shuttle was found to be damaged, not allowing the firing mechanism to properly function.While no conclusion could be reached as to how the firing shuttle became damaged; it should be noted that a 100% inspections takes place during manufacturing to ensure the device meets the require specifications prior to shipments, in addition, a sample of the batch is inspected at (b)(4).

Event Description

It was reported that during an unknown procedure, the device was found to be defective.No further information is known at this time.There was no adverse patient impact reported.

• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5375006
• MDR Text Key: 36634726
• Report Number: 3005075853-2016-00404
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K051002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2019
• Device Catalogue Number: SC60
• Device Lot Number: L9175G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/07/2016
• Initial Date FDA Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1