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

Model Number PSEE60A

Device Problems Unintended Ejection (1234); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 4/26/2023.D4: batch # unk.A manufacturing record evaluation was performed for the finished device lot/batch number, x95n3r, and no non-conformances were identified.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.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 the stapler popped reload out and jammed.Reverse blade button not functional.No patient consequences reported.No further information is available.

Manufacturer Narrative

(b)(4).Date sent: 7/28/2023.D4: batch # 925a30.Investigation summary.The product was returned to ethicon endo-surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that one psee60a device was returned with no apparent damage, with no reload present, with the jaws and trigger in the close position.Also, the knife was noted partially advance, the knife reverse switch was activated and the knife returned to the home position as expected.The device was tested for functionality in the straight position with a test reload and achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the staples meet the staple release criteria.Although no conclusion could be reach on the cause of the reported event, the instructions for use do contain the following caution: for the cartridge retention, insert the reload by sliding it against the bottom of the cartridge jaw until the cartridge alignment tab stops in the reload alignment slot.Snap the reload securely in place.Remove the staple retaining cap and discard.For the would not reverse button force, slide the knife reverse switch forward to return the knife to home position.At any time, if the knife reverse switch does not return the knife to home position and the jaws will not open.First, ensure the battery pack is securely installed and the instrument has power then, try the knife reverse switch again.If the knife still does not return, use the manual override.The event described could not be confirmed as the device performed without any difficulties noted.The test reload was placed and removed with no issues noted during functional testing. the knife reverse button worked properly during testing.Device history review.A manufacturing record evaluation was performed for the finished device batch number 925a30, and no non-conformances were identified.

• 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 16816077
• MDR Text Key: 314025547
• Report Number: 3005075853-2023-02847
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PSEE60A
• Device Catalogue Number: PSEE60A
• Device Lot Number: X95N3R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1