MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD UNKNOWN VLOC ENDO STITCH RELOAD ABS; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number UNKNOWN VLOC ENDO STITCH RELOAD ABS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Title: short-term outcomes of nonrobotic single-incision laparoscopic sacrocolpopexy: a surgical technique source: juan liu, md, phd, jaden kohn, md, mph, chunhua wu, md, zhenkun guan, ms, and xiaoming guan, md, phd, 2019, (b)(4).If information is provided in the future, a supplemental report will be issued.(b)(4).

Event Description

According to literature source of study performed from october 2016 to november 2017, during single incision laparoscopic sacrocolpopexy (s-lsc) for the treatment of pelvic organ prolapse, suture was used to anchor the mesh to the vaginal fascia.Of the 49 patients included in the analysis, three patients developed apical vaginal mesh exposure: of these, one patient was symptomatic (blood tinged vaginal discharge 1 month after s-lsc) which was relieved by topical application of estriol ointment.The other two patients were asymptomatic, but mesh exposure was noted on a physical examination 3 months after s-lsc and were continuing to be observed.One patient had lumbosacral pain 1 month after s-lsc, which was relieved by the application of traditional chinese massage for 1 week.Additionally, six patients complained of new onset of stress urinary incontinence: of these, 1 case underwent a tension-free vaginal suspension, 2 cases improved with pelvic floor training, and 3 cases were continuing to be observed.

• Brand Name: UNKNOWN VLOC ENDO STITCH RELOAD ABS
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 9281031
• MDR Text Key: 165543088
• Report Number: 9612501-2019-02133
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN VLOC ENDO STITCH RELOAD ABS
• Device Catalogue Number: UNKNOWN VLOC ENDO STITCH RELOA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention