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

Model Number	TLH30
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2003
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Only event year known: 2003; captured as citation date.Batch # unknown.This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot/batch number has not been provided.
Event or Problem Description
It was reported via journal article: title: intercostal drain migration post esophagectomy.Author : j.A.Gossage, a.O.Chukwuemeka, j.E.Dussek.Citation: diseases of the esophagus (2003) 16, 268¿269.The placement of an intercostal drain is routine after a thoracotomy.The drain will be removed when the drainage has ceased, there is no air leak and the lung has fully expanded.The erosion of an intercostal drain into the stomach cavity after an elective esophagectomy has not been reported before.Reported complications included : a case of a 38-year-old man with a tumor of the distal third of the esophagus and subsequent biopsies confirmed a squamous cell carcinoma underwent an ivor¿lewis esophagectomy.The lesser curvature was closed using a proximate tlh30 (johnson and johnson, bracknell berks., uk) reloadable linear stapler and the free end of the esophagus anastomosed to the stomach remnant using continuous 3.0 polydioxanone.A single intercostal drain was placed in the paravertebral gutter under direct vision.On the fifth day there was a large increase in drainage volume.1250 ml of cloudy brown fluid drained from the right pleural space.The patient had increased tenderness over the right side of the chest and a chest radiograph revealed a large rightsided pleural effusion.A further gastrograffin swallow showed a confined leak at the distal extremity of the gastric staple line.Surgical intervention was proposed but rejected by the patient.The leak was managed conservatively and peripheral total parenteral nutrition was commenced.The intercostal drain continued to drain large volumes of fluid, although the patient remained clinically well.The patient reported that the drainage seemed to increase when he lay flat or on his right hand side.On the fourteenth day, a repeat gastrograffin swallow showed a narrowing of the pylorus, but no leak.The pylorus was dilated using balloon dilatation to ensure adequate gastric emptying and a further gastro graffin swallow was done the next day.Again no abnormality was seen.A nasogastric tube was placed and octreotide started.Significant quantities of fluid continued to drain and a persistent gastric leak was confirmed by the presence of oral methylene blue in the intercostal drain.Esophagogastroscopy was planned as a prelude to surgical closure of the gastric leak.At gastroscopy the intercostal drain was seen to have eroded into the stomach.No other lesions were visible and the gastric mucosa appeared normal.The intercostal drain was withdrawn from the stomach and no further drainage was recorded.The patient was commenced on a light diet and discharged 5 days later.At the week follow up he was well and keen to get back to work.It was concluded, that in this case gastroscopy was fundamental in making the diagnosis.Early upper gastrointestinal endoscopy in complicated cases is recommended.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 11752397
• Report Number: 3005075853-2021-02396
• Device Sequence Number: 4167924
• Product Code: GDW
• UDI-Device Identifier: 10705036013228
• UDI-Public: 10705036013228
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/06/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: TLH30
• Device Catalogue Number: TLH30
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 04/30/2021
• Patient Sequence Number: 1