MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PWRD 23MM CURVED CIRCULAR, 18CM SHAFT; STAPLE, IMPLANTABLE

Catalog Number	CDH23P
Medical Device Problem Codes	Use of Device Problem (1670); Failure to Fire (2610); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 6/10/2024.Additional information received: the surgeon did not install the battery in right way, which caused the device not fire.There was no cut or staple.However, the long time compression to tissue caused the tissue oozing.Thus, the surgeon changed to open operation to complete the procedure with suture.What were the indications for surgery? low rectal carcinoma operation.What surgical procedure was performed? end-to-end anastomosis.Did the patient receive any preoperative chemotherapy or radiation? unknown.Were there any issues experienced with the device in the initial surgical procedure? unknown.What healthcare professional fired the device and what is his/her experience with the device? a new surgeon.Experience unknown.Where in the green gap setting scale was the indicator located prior to firing (low-b, middle-b, or high-b)? unknown.Did the healthcare professional wait 15 seconds after closing the device and then retighten prior to firing? unknown.Were there any issues with device use/firing? not fired.What confirmation was received that the device completed the firing sequence? not fired.Was the green checkmark visible at the end of the firing? not fired.How many counter-clockwise revolutions of the adjusting knob were used to open the device? unknown.Was there any difficulty removing the device? no.Was a complete transection of the white breakaway washer visually confirmed? not fired.Were the donuts inspected? if so, please describe.Not fired.No cut.Were there any issues noted with staple formation? if so, please describe the shape and location.Not fired.No cut or staple.Does the surgeon believe the post-operative complications were related to an alleged deficiency of the device or were there other contributing factors to include patient tissue condition? no.
Event or Problem Description
It was reported that during an unknown procedure, after the fire, noted the device cut the tissue without staple deployed.Changed to open operation to complete the surgery.No additional information could be provided.
Additional Manufacturer Narrative
(b)(4) date sent 5/13/2024 d4 batch # unk an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.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: 1.Could you please clarify if there were any patient consequences? 2.Could you please clarify if there was any change in the post-operative care of the patient as a result of the event? 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.

• Brand Name: PWRD 23MM CURVED CIRCULAR, 18CM SHAFT
• Common Device Name: 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: 19297603
• Report Number: 3005075853-2024-03553
• Device Sequence Number: 14916808
• Product Code: GDW
• UDI-Device Identifier: 10705036015369
• UDI-Public: 10705036015369
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K163523
• 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,Followup
• Report Date (Section B): 06/10/2024

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: 04/30/2024
• Device Catalogue Number: CDH23P
• Device Lot Number: V9524F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2021
• 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
• Patient Sex: Unknown