MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RL TITAN HEAVY WIRE; STAPLE, IMPLANTABLE

Model Number	TLH60
Medical Device Problem Codes	Failure to Fire (2610); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Abscess (1690); Unspecified Infection (1930); Obstruction/Occlusion (2422)
Date of Event	01/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a low anterior resection.The patient had a history of constipation and complex pelvic cystic mass (> 15 cm) underwent mass resection was deemed necessary.Medical records provided state that preoperatively, the mass appeared to be separate from the lumen of the rectum; however, intraoperatively the surgeon felt they could not resect this mass without a low anterior resection of the rectum.Operative note further states a ¿ta stapler¿ was fired across the distal rectum, which appeared to fire without difficulty.Dissection was continued along the caudal aspect of the mass with ligasure and the mass and rectal tissue were excised.Upon digital examination of the stump, it was determined that the entire ta staple line failed ¿appeared as if no staples had fired across the small bowel.¿ surgeon performed an interrupted handsewn closure of the rectal stump and ¿repeat digital rectal examination demonstrated an intact rectal pouch.¿ an end-to-end anastomosis was performed between the rectal stump and the distal sigmoid colon ¿despite the fact that we knew there would be high risk of leak, we felt this was our best opportunity for long term continence and restoration of bowel continuity.¿ a ¿29 anvil for an eea stapler¿ was used.The circumferential staple line appeared to be intact, but an air leak test demonstrated a leak and sutures were placed between the sigmoid colon and rectal stump, which resulted in an improvement but still some leaking.A jp drain was placed in the pelvis, and a diverting loop ileostomy was then performed.On pod 5, patient developed small bowel obstruction and patient was made npo and ng tube placed.The obstruction resolved and patient transferred to a skilled nursing facility on pod 19, where she continued to have drainage from the incision site and ileostomy site.She was therefore readmitted to the hospital and received antibiotics for intraabdominal abscess.Patient had several readmissions for repeat infections and reoperations.Patient¿s ileostomy was ultimately reversed ten months following the initial surgery.
Additional Manufacturer Narrative
(b)(4).Batch # unk.Event date: only event year known: 2016.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).Date sent: 05/24/2022.

• 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: orla o'mahony ; 475 calle c; guaynabo
• MDR Report Key: 14436601
• Report Number: 3005075853-2022-03212
• Device Sequence Number: 5579136
• Product Code: GDW
• UDI-Device Identifier: 10705036013235
• UDI-Public: 10705036013235
• Combination Product (Y/N): N
• PMA/510(K) Number: K020779
• 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,Followup
• Report Date (Section B): 05/18/2022

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 Expiration Date: 08/31/2020
• Device Model Number: TLH60
• Device Catalogue Number: TLH60
• Device Lot Number: M4J16K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/29/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 77 KG