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

Catalog Number	STR5G
Health Effect - Clinical Codes	Dyspnea (1816); Pulmonary Emphysema (1832); Pain (1994)
Date of Event	07/02/2008
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.
Event or Problem Description
It was reported via literature entitled: mediastinal and retro-/intraperitoneal emphysema after stapled transanal rectal resection (starr-operation) using the contour transtar stapler in obstructive defecation syndrome.Author: tobias schulte, frank bokelmann, johannes jongen, hans-gunter peleikis, fred fandrich, volker kahlke.Citation: int j colorectal dis (2008) 23:1019¿1020, doi 10.1007/s00384-008-0516-y; published online: 2 july 2008.This case shows the history of a patient who developed a retro-/intraperitoneal and mediastinal emphysema following ¿transtar-operation¿.A (b)(6)-year-old woman was transferred to the medical emergency room by the surgeon in charge with dyspnea and pain in the neck.The past medical and surgical history only showed a medical consultation because of a rectocele with defecation problems.The day before, a starr-operation using the contour transtar curved cutter stapler® was performed in general anaesthesia with endotracheal intubation.During the clinical examination she showed an emphysema of the neck.The chest x-ray showed a mediastinal and neck emphysema.Subsequent a flexible rectoscopies was performed which showed beside small amounts of blood sufficient stapler sutures without any evidence of an insufficiency.A conservative therapy with i.V.Antibiotics and only clear fluids for oral intake was started.During the following days the clinical status remained stable.The patient returned to solid food after 3 days and was discharged in a clinical good condition 7 days after admission.In conclusion, the starr-operation is a quite new surgical technique and used to treat obstructive defecation syndrome.It has been reported as a very effective treatment with low morbidity.However, the authors noted that starr operation should be restricted to experienced colorectal surgeons due to the risk of complications.

• Brand Name: CONTOUR TRANSTAR STAPLER SET
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7743912
• Report Number: 3005075853-2018-11821
• Device Sequence Number: 1258263
• Product Code: GDW
• UDI-Device Identifier: 20705036002878
• UDI-Public: 20705036002878
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/09/2018

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 Catalogue Number: STR5G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 08/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention