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

Model Number	PCE45A
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # u5ck2x.(b)(4).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 with an ecr45g reload (b) not loaded in the device.This reload was received fully fired.Additionally, one ecr45w reload (c) was received, this reload was received fully fired, another ecr45w reload (d) was received partially fired 1/10.Upon evaluation of the reload (d) the one-piece sled was noted to be damaged.No obvious damage to the reload deck was noted, which suggests the reload, may not have been fired over a hard object.As additional testing, 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.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.It should be noted that product failure is multifactorial.The damage to the one-piece sled has been correlated to the design.This product issue will be addressed through ethicon endo surgery¿s quality system.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during the left lung tumor resection surgery, could not fire when severing pulmonary tissue on the 2nd firing.Changed the new one to complete surgery.There was no patient consequence reported.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
• MDR Report Key: 11693178
• Report Number: 3005075853-2021-02116
• Device Sequence Number: 11547811
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2021

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: 04/30/2023
• Device Model Number: PCE45A
• Device Catalogue Number: PCE45A
• Device Lot Number: U9468H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 04/20/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ECR45G.; ECR45W X2.