MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PWRD ECH FLEX 60MM 28CM SHAFT; STAPLE, IMPLANTABLE

Catalog Number	PCE60A
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 6/7/2024.D4: batch # 590c73.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that one pce60a device was returned with the anvil bent upwards, the anvil knife slot damaged and joint cover damaged, with a gst60w reload(b) present, the reload was received partially fired 1/16.In addition, a reload pan was found lodged inside the channel.No functional test was performed due to the condition of the device.In addition, the knife was noted to be partially advanced.The knife reverse switch was activated, however, the knife was not able to return to home position due to the condition of the knife slot.The damage on the joint cover, it is possible that the device was attended to be pulled out from a trocar in the articulated position, resulting in the edge of the trocar damaging the joint cover.Please reference the instruction for use for more information.It is possible that while loading the reload, the reload was pushed farther back than the reload alignment slot resulting in the knife pushing the one-piece sled forward and locking the reload.Please reference the instruction for use for more information.It is possible that the combination of tissue and/or buttressing material compressed between the device jaws may have been beyond indicated thickness or tissue that cannot compress to the indicated range for the selected reload.This may have caused excessive force to be applied to the underside of the solid steel anvil leading to this damage.Please reference the instruction for use for more information.It is also possible that handling by the customer could dislodge the pan.Dislodgement as a result of the removal of the reload from the device is the most likely scenario.Please reference the instruction for use for more information.Device history review: a manufacturing record evaluation was performed for the finished device batch number 590c73, and no non-conformances were identified.
Event or Problem Description
It was reported that during the unk surgery, could not fire farther after fired a little.Changed the new one to complete surgery.There was no patient consequence reported.No additional information can be provided.

• Brand Name: PWRD ECH FLEX 60MM 28CM SHAFT
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 19491042
• Report Number: 3005075853-2024-04168
• Device Sequence Number: 12521877
• Product Code: GDW
• UDI-Device Identifier: 10705036014478
• UDI-Public: 10705036014478
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/07/2024

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: 07/23/2026
• Device Catalogue Number: PCE60A
• Device Lot Number: 590C73
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GST60W
• Patient Sex: Unknown