MAUDE Adverse Event Report: MEDTRONIC ENGINEERING AND INNOVATION CENTER (MEIC) ENDO STITCH; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Patient Problems Wound Dehiscence (1154); Pain (1994); Post Traumatic Wound Infection (2447)

Event Date 06/08/2022

Event Type  Injury  

Event Description

I had a laparoscopic hysterectomy and according to my medical report the needle of the endo stitch device came off midway during suturing and had to be recovered.The needle was replaced and the original suture was removed and a second suture was done.However, 13 weeks after my surgery, i experienced vaginal cuff dehiscence.I have no risk factors that would have contributed to this and i was medically cleared at 7 weeks post op to continue normal activities.The dehiscence was incredibly painful and i had to have repair surgery in addition to having extreme infection addressed.I went to the er (emergency room) on (b)(6) 2022, and my white blood cell count was flagged but i was misdiagnosed.A ct scan was done and the attending dr said it didn't show dehiscence but no physical examination was done.Reference report: mw5151010.

• Brand Name: ENDO STITCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): MEDTRONIC ENGINEERING AND INNOVATION CENTER (MEIC)
• MDR Report Key: 18639685
• MDR Text Key: 334551988
• Report Number: MW5151011
• 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: Patient
• Type of Report: Initial
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: VALTREX AS NEEDED.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White