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

Model Number PSEE60A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #u5dc2y.Attempts have been made to retrieve the device.To date, the device has not been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/batch.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during an unknown procedure, the inner package was improperly sealed.There were no patient consequences.No additional information is available at this time.

Manufacturer Narrative

(b)(4).Date sent: 11/17/2020.D4: batch # u5dc2y.Investigation summary the analysis results found that a tyvek was returned with no apparent damaged.Upon visual inspection of the tyvek, no damaged was noted to be on it and seal area was noted completed.As part of our quality process, the manufacturing records of this lot number were reviewed, and the manufacturing standards were met prior to the release of this lot.Event could not be confirmed as no damaged was noted on the tyvek.It should be noted that as part of our quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: POWERED 60 ECHELON +, 340MM SHAFT
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10698490
• MDR Text Key: 214152458
• Report Number: 3005075853-2020-05379
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036014607
• UDI-Public: 10705036014607
• Combination Product (y/n): N
• PMA/PMN Number: K110385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 09/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: PSEE60A
• Device Catalogue Number: PSEE60A
• Device Lot Number: U94T5V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Date Manufacturer Received: 10/20/2020
• Patient Sequence Number: 1