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

Model Number 173016

Device Problems Break (1069); Positioning Problem (3009); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2022

Event Type  malfunction  

Event Description

The surgeon was using the endo stitch with v-loc 180 absorbable sutures.The endo stitch failed to work after two sutures.The surgeon felt the v-loc 180 absorbable sutures were positioned wrong from the manufacturer.The surgeon called for another endo stitch with v-loc 180 absorbable sutures.The second endo stitch failed to work.The surgeon felt the v-loc 180 absorbable sutures were positioned wrong from the manufacturer.The surgeon called for a third endo stitch with v-loc 180 absorbable sutures.On placement of the first suture the tip of the endo stitch broke off while inside the vaginal cuff tissue.The surgeon was unable to see the tip of the endo stitch.X-ray was performed to locate the tip of the endo stitch.Once located the vaginal tissue contained the tip of the endo stitch was excised.Decision was then made to complete the closure vaginally.Vicryl suture was used to close the vaginal cuff.A cystoscopy was then performed.Patient taken to recovery in stable condition.No untoward patient effects.

• Brand Name: ENDO STITCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN LP; 60 middletown ave.; north haven CT 06473
• MDR Report Key: 14999728
• MDR Text Key: 295782644
• Report Number: 14999728
• Device Sequence Number: 1
• Product Code: OCW
• 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: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 173016
• Device Catalogue Number: VLOCA006L
• Device Lot Number: N2D0240Y
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17155 DA
• Patient Sex: Female