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

Model Number	173016
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
"malfunction of endo stitch suturing device, reference number 173016.Lot j5e3790ey, udi: (b)(4).During procedure, 0 silk es-9 endo-needle was dropped from suturing device due to malfunction while suturing tissue.Per dr.[redacted], it would cause more patient trauma trying to remove the needle than to leave it behind.Event was documented in surgical counts and needle was documented as a retained packed item in flowsheets/avatar.Needle was seen and verified by surgeon on post-op xray.".

• Brand Name: ENDO STITCH
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN LP; 60 middletown ave; north haven CT 06473
• MDR Report Key: 25408140
• Report Number: 25408140
• Device Sequence Number: 10743650
• Product Code: OCW
• UDI-Device Identifier: 10884521100008
• UDI-Public: (01)10884521100008
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 05/14/2026
• Report Date (Section F): 05/14/2026

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 Lot Number: J5E3790EY
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2026
• 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 Sex: Unknown
• Date Report Sent to FDA: 05/14/2026