ENDO STITCH 173016

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-10 for ENDO STITCH 173016 manufactured by Coviden.

Event Text Entries

[38425252] Pt admitted to the hospital to undergo total laparoscopic hysterectomy. While beginning to close the vaginal cuff using the endo stitch device through the 12 mm umbilical port, on the first stitch there was a premature separation of the endo stitch needle from the suture with the needle retained in the posterior vaginal cuff. Radiology came in with the c-arm and the needle was identified. A 4 to 5 mm section of the vaginal cuff from a vaginal approach was resected and sent to pathology. X-ray was taken and the needle was no longer visible after its removal. The vaginal cuff and peritoneum were then reapproximated from the vaginal approach using sequential figure of eight stitches. Diagnosis or reason for use: endoscopic approach to stitch the vaginal cuff.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW5060200
MDR Report Key	5440597
Date Received	2016-02-10
Date of Report	2016-02-10
Date of Event	2015-12-08
Date Added to Maude	2016-02-17
Event Key	0
Report Source Code	Voluntary report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	3
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	3
Previous Use Code	3
Event Type	3
Type of Report	0

Device Details

Brand Name	ENDO STITCH
Generic Name	APPROXIMATION DEVICE
Product Code	MFJ
Date Received	2016-02-10
Model Number	173016
Operator	HEALTH PROFESSIONAL
Device Availability	N
Device Eval'ed by Mfgr	*
Device Sequence No	1
Device Event Key	0
Manufacturer	COVIDEN
Manufacturer Address	US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2016-02-10