MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-12 for STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL SXPD1B401 manufactured by Surgical Specialties Puerto Rico, Inc..
[94507180]
Patient Sequence No: 1, Text Type: N, H10
[94507181]
A female patient presented for a planned robotic-assisted laparoscopic supracervical hysterectomy with bilateral salpingo-oophorectomy, sacrocolpopexy and sling procedure, secondary to a symptomatic cystocele with stress urinary incontinence. These procedures were completed with the coordination of the urology and gynecology services. Prior to the procedure, both surgeons ensured that the history and physical and informed consents were completed and available to the operating room staff. This was an elective case that was the first scheduled case of the day. The surgery started at with the gynecological surgeon at 0900. The urology surgeon is notified about 5-10 minutes before that the gynecological portion of the surgery is completed. When the urologist enters, another time out is completed. The urologists completed the procedure without complications. The patient was discharged the next day. The patient presented to the emergency department 10 days later with abdominal distention, nausea, vomiting, and constipation. A ct scan of the abdomen revealed a small bowel obstruction. The next day she was brought to the operating room after no improvement of her symptoms. The surgeon found a barbed stratafix suture going around the distal portion of the ileum. The stitch was most likely from closing the peritoneum during the original surgery. The suture was cut and the obstruction was immediately resolved. Urology assessed the sling which was without issue. The operation was completed. The patient remained in the hospital until her ileus was completely resolved and was discharged home 10 days later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7107889 |
| MDR Report Key | 7107889 |
| Date Received | 2017-12-12 |
| Date of Report | 2017-12-08 |
| Date of Event | 2015-11-09 |
| Report Date | 2017-12-08 |
| Date Reported to FDA | 2017-12-08 |
| Date Reported to Mfgr | 2017-12-08 |
| Date Added to Maude | 2017-12-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| 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 | 3 |
| Brand Name | STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL |
| Generic Name | SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE |
| Product Code | GAO |
| Date Received | 2017-12-12 |
| Model Number | SXPD1B401 |
| ID Number | 30CM |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SURGICAL SPECIALTIES PUERTO RICO, INC. |
| Manufacturer Address | SCOTT COHN 247 STATION DRIVE, NE1 WESTWOOD MA 02090 US 02090 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2017-12-12 |