MAUDE Adverse Event Report: COVIDIEN LP ENDO STITCH; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number 173016

Device Problem Physical Resistance/Sticking (4012)

Patient Problems Pain (1994); Intermenstrual Bleeding (2665)

Event Date 04/10/2023

Event Type  malfunction  

Event Description

Mid-60¿s female with history of post-menopausal bleeding and pelvic pain.Procedure: total laparoscopic hysterectomy, bilateral salpingo-oophorectomy, repair of bladder, cystoscopy and removal of vaginal nodule.During the procedure, the needle would not dislodge from the unit.A new device used to finish the procedure.No known harm to patient.Manufacturer response for endoscopic tissue approximation device, endo stitch (per site reporter).Will obtain.

• Brand Name: ENDO STITCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 16814746
• MDR Text Key: 314015604
• Report Number: 16814746
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10884521100008
• UDI-Public: (01)10884521100008(17)270228(10)J2C0599EY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 173016
• Device Lot Number: J2C0599EY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Female
• Patient Weight: 98 KG