MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-03-23 for ENDO STITCH 10MM SUTURING DEVICE 173016 manufactured by Ussc Puerto Rico.
[2571903]
Procedure type: hysterectomy. According to the reporter, the v-loc needle/suture detached from the jaws of the endostitch while being passed through the tissue. Another reload and endostitch were used. The needle was cut loose. A new reload was used to complete the closure. There was no bleeding reported in excess of 250cc. The case was not extended by more than 30 minutes. Nothing fell into the cavity. There was no tissue damage or unanticipated tissue loss.
Patient Sequence No: 1, Text Type: D, B5
[9709203]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647580-2012-00198 |
| MDR Report Key | 2514157 |
| Report Source | 05 |
| Date Received | 2012-03-23 |
| Date of Report | 2012-02-27 |
| Date of Event | 2012-02-27 |
| Date Mfgr Received | 2012-02-27 |
| Device Manufacturer Date | 2011-10-01 |
| Date Added to Maude | 2012-08-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TERRY CALLAHAN |
| Manufacturer Street | 60 MIDDLETOWN AVENUE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034926273 |
| Manufacturer G1 | USSC PUERTO RICO |
| Manufacturer Street | BUILDING 911-67 SABANETAS INDUSTRIAL PARK |
| Manufacturer City | PONCE PR 00731 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00731 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDO STITCH 10MM SUTURING DEVICE |
| Generic Name | DISPOSABLE SUTURING DEVICE |
| Product Code | MFJ |
| Date Received | 2012-03-23 |
| Catalog Number | 173016 |
| Lot Number | N1K0559X |
| Device Expiration Date | 2016-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | USSC PUERTO RICO |
| Manufacturer Address | BUILDING 911-67 PONCE PR 00731 US 00731 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-23 |