MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. POWERED 60 ECHELON +, 340MM SHAFT; STAPLE, IMPLANTABLE

Catalog Number PSEE60A

Device Problems Break (1069); Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch t5a59c.Investigation summary: the analysis results found that psee60a device was returned inside its package opened.Upon visual inspection, it was observed that the blister and tyvek from the packaging were damaged.The blister was noted to be broken.It was noted to have a hole in the tyvek, the hole was noted to be from the outside in.Due to the damages found on the packaging, a possible cause for these conditions is due to improper handling during transit or storage; it appears that the package hit a pointy surface and this caused the reported event.The reported complaint was confirmed.All ees product is 100% inspected prior to release.The information you provided is compiled monitored and reviewed on a routine basis for any associated trends.A manufacturing record evaluation was performed for the finished device lot t9254n number, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch t5a59c number, and no non-conformances were identified.

Event Description

It was reported that during an exploratory lap, they opened the device and the packaging container was cracked and broken.Case completed with another device of the same product code.There were no patient consequences reported.

• Brand Name: POWERED 60 ECHELON +, 340MM SHAFT
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8561295
• MDR Text Key: 143582953
• Report Number: 3005075853-2019-18352
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036014607
• UDI-Public: 10705036014607
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/02/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: PSEE60A
• Device Lot Number: T9254N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 04/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1