MAUDE Adverse Event Report: MEDTRONIC/ COVIDIEN ENDOSTITCH INSTRUMENT; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number 173016

Device Problems Break (1069); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 11/16/2021

Event Description

The complainant reported that on (b)(6) 2021, "dr (b)(6) with dr.(b)(6) assisting, were performing a laparoscopic total hysterectomy and bilateral salpingectomy.They notified the operating room team that while using the endostitch suturing device, a vloc needle broke in half.Half was immediately retrieved from the abdomen, and the remaining needle piece was successfully retrieved from the abdomen within 5 minutes.Dr.(b)(6) requested a second endostitch device.The first was passed off and no longer in use.Additional vloc needle loads were requested.While using the fourth vloc needle, it broke in half inside the patient's abdomen.Half of the needle was immediately retrieved from the abdomen.The remaining piece could not be identified with the laparoscope.Immediate actions taken: dr.(b)(6) was called to scrub in and assist.Patient was re-positioned to supine for best portable xray view.Radiologist was consulted.A c- arm was used to assist with locating the remaining needle piece.The patient was repositioned, and the needle piece removed 2 hours later." there were 2 of these devices received and 2 were deficient and they were disposed of and/or destroyed.No injury or illness was reported.

• Brand Name: ENDOSTITCH INSTRUMENT
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): MEDTRONIC/ COVIDIEN
• MDR Report Key: 13783263
• MDR Text Key: 287433459
• Report Number: MW5108190
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/06/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 173016
• Device Lot Number: J1D1612EY
• Patient Sequence Number: 1