MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PWRD ECH FLEX 45MM 28CM SHAFT; STAPLE, IMPLANTABLE

Model Number	PCE45A
Medical Device Problem Codes	Failure to Fire (2610); Difficult to Open or Close (2921); Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # u5cn2l.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 pce45a device was returned with no apparent damage and with two ecr45d reloads present.The reloads (b & c) were received partially fired 1/16.After further evaluation, the bulkhead contacts were noted to be damaged making the instrument non-functional.No functional test was performed due to the condition of the device.As part of our quality process, the manufacturing records of this batch number were reviewed, and the manufacturing standards were met prior to the release of this batch.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The damage to the bulkheads contacts has been correlated to a manufacturing process.This product issue will be addressed through ethicon endo surgery¿s quality system.The condition of the reload: it is possible that while loading the reload, the reload was pushed farther back than the reload alignment stop windows resulting in the knife pushing the one piece sled forward and locking the reload.Please reference the instruction for use for more information.Reload b: ecr45d, 282a18, partially fired 1/16.Reload c: ecr45d, 123a16, partially fired 1/16.
Event or Problem Description
It was reported that during the right lung segmentectomy surgery, could not fire when severing lung tissue on the 4th firing.Checked the sled¿s position, it is lockout issue.Changed the new one and then the knife moved to the distal end, but could not return knife automatically.Knife reverse button could not work.Used manual override lever to return knife.There were no adverse consequences to the patient.No additional information can be provided.

• Brand Name: PWRD ECH FLEX 45MM 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: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 12851560
• Report Number: 3005075853-2021-07092
• Device Sequence Number: 3992752
• Product Code: GDW
• UDI-Device Identifier: 10705036014461
• UDI-Public: 10705036014461
• Combination Product (Y/N): N
• 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): 11/22/2021

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: 04/28/2025
• Device Model Number: PCE45A
• Device Catalogue Number: PCE45A
• Device Lot Number: U94L32
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ECR45D X2.
• Patient Sex: Unknown