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

Model Number	173016
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Laparoscopic hysterectomy uncomplicated until closure- the vaginal cuff was closed with endostitch device and when back suture to lock the suture in place occurred the needle when toggled was embedded in tissue and dislodged from the endostitch device- upon removal suture broke off of the needle which remained retained in cuff- multiple attempts completed to remove needle vaginally and laparoscopically- c- arm fluoroscopy performed showing the needle in situ left by pubic rami where concern needle in vaginal cuff noted.Unable to be palpated or located in resected tissue.Magnet used to try and locate in tissue laparoscopically and vaginally and unable to be found.Tissue resected but given close to bladder edge and nearing vascular pedicle decision was made to abandon removal and cuff was closed vaginally.

• Brand Name: ENDO STITCH
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 24505589
• Report Number: 24505589
• Device Sequence Number: 10593419
• Product Code: OCW
• UDI-Device Identifier: 10884521100008
• UDI-Public: (01)10884521100008
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2026
• Report Date (Section F): 02/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: J5A2935EY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR
• Patient Sex: Female
• Date Report Sent to FDA: 02/26/2026