MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. CONTOUR CURVED CUTTER STAPLER; STAPLE, IMPLANTABLE

Model Number	CS40B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Adhesion(s) (1695)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 5/24/2023.B3: only event year known: 2018.D4: batch # unk.No lot or batch number was provided therefore a device history could not be done.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.
Event or Problem Description
A patient underwent surgery for a 9 year history of colitis and ulcerative colitis requiring maximizing medical therapy and requiring essentially continuous steroid boluses.Patient underwent a planned 3-stage procedure with a total abdominal colectomy, j pouch placement, and diverting loop ileostomy.Surgeon noted chronic inflammatory changes around the entire colon, consistent with active colitis.Operative note states surgeon divided the terminal ileum with a ¿gia 100 stapling device¿ across the ascending and transverse colon.Surgeon also noted formed stool and significant inflammatory changes around the entire colon despite patient undergoing mechanical and antibiotic bowel prep.Surgeon used a ¿contour stapling device¿ to staple across the distal bowel, and then a clamp-and-tie technique across the mesorectum.No difficulties noted with use of the stapler, adequate hemostasis was ensured, an end ileostomy along the right abdominal wall was performed and an incisional wound vac was placed.The patient was discharged on pod 5.A few days later, the patient developed abdominal pain and ct scan revealed dehiscence of the suture line of the proximal rectal pouch and patient underwent exploratory laparotomy on pod 7 during which significant adhesions of the omentum and a large cavity of purulent material in the right pericolic gutter, and a breakdown of the staple line at the rectal stump was seen.Small portions of a ¿tia stapler¿ was used to stabilize the rectal stump 1 cm from the previous staple line and this staple line was oversewed with 4-0 pds in running fashion.A repeat ct scan performed was negative and the patient was again discharged.Four days later.Patient had increasing drainage from his midline wound and his remaining jp drain, and was therefore readmitted.Ct scan performed that day revealed a small amount of free fluid in the lower abdomen, but no definite well-formed fluid collections.Patient had an uneventful hospital course and was discharged on (b)(6) 2018.

• Brand Name: CONTOUR CURVED CUTTER STAPLER
• 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: 16993805
• Report Number: 3005075853-2023-03512
• Device Sequence Number: 15213730
• Product Code: GDW
• UDI-Device Identifier: 10705036012399
• UDI-Public: 10705036012399
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CS40B
• Device Catalogue Number: CS40B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 05/24/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 4-0 PDS; GIA 100 STAPLING; TIA STAPLER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR
• Patient Sex: Male