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

Model Number	PCE60A
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Was the device locked on tissue with the jaws closed? if yes, how was the device removed? what troubleshooting steps were attempted to open the device (e.G.Squeezing the closing trigger while simultaneously depressing the anvil release button, knife reverse switch, manual override)? did the jaws eventually open? was there any patient consequence or change in the post-operative care of the patient as a result of the event? (extended hospital stay, readmission, re-operation, etc.) what is the most current patient health status and condition? investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.
Event or Problem Description
This case is from health authority.It was reported that during the surgery, after fired, could not open the jaw, and a small spring fell from the gap of the red excitation key.Changed the new one to complete surgery.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: 16197586
• Report Number: 3005075853-2023-00391
• Device Sequence Number: 17644009
• 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): 01/18/2023

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 Model Number: PCE60A
• Device Catalogue Number: PCE60A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown