MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PWRD 29MM CURVED CIRCULAR, 18CM SHAFT; STAPLE, IMPLANTABLE

Catalog Number CDH29P

Device Problems Failure to Cut (2587); Adverse Event Without Identified Device or Use Problem (2993); Failure to Eject (4010)

Patient Problems Failure to Anastomose (1028); Adhesion(s) (1695); Hernia (2240)

Event Date 02/04/2022

Event Type  Injury  

Event Description

The patient underwent a sigmoid colectomy for distal sigmoid colon cancer on (b)(6) 2022.Per the operative report, the surgeon created a ¿side-to-end stapled anastomosis using a circular stapler.¿ the surgeon experienced an issue removing the stapler after firing, and ultimately noted that the ¿white ring from the anvil was in the subcutaneous tissue at the pfannenstiel insertion port.¿ the surgeon concluded that the ¿stapler could not be removed¿ because ¿it had not transected the tissue of the proximal ring correctly.¿ the surgery was converted to open, and the anastomosis was re-performed with ¿a new 29 mm powered stapler.¿ the surgeon noted that there was very thick pericolic fat, resulting in a ¿very thick walled anastomosis.¿ there was some leaking during the air leak test, and the anastomosis was reinforced with vicryl sutures until there was no leak.Several more leak tests were performed over the next 45 to 60 minutes to ensure that the anastomosis was secure.A flexible sigmoidoscopy was also performed and revealed a viable and healthy anastomosis without evidence of bleeding.The patient was treated for a ¿small anastomotic leak¿ postop and a picc line was placed.The claimant¿s attorney reports that the patient was discharged 12 weeks later.The patient also had an exploratory laparotomy for lysis of adhesions and an incisional hernia repair ten months later.

Manufacturer Narrative

(b)(4).Date sent 3/29/2024.D4 batch # unk.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.However, if the product is received at a later date, the investigation will be updated as applicable.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.

Manufacturer Narrative

(b)(4).Date sent: 4/17/2024.See attached op notes.

• Brand Name: PWRD 29MM CURVED CIRCULAR, 18CM SHAFT
• Type of Device: 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 ; PR ; 3035526892
• MDR Report Key: 19003391
• MDR Text Key: 338898804
• Report Number: 3005075853-2024-02487
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036015383
• UDI-Public: 10705036015383
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163523
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDH29P
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 107 KG