MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2013-08-28 for PURSTRING INSTRUMENT 215 020240 manufactured by Covidien, Formerly Us Surgical.
[20353069]
Procedure: sigmoid resection. According to the reporter: the staples for the purse-string suture did not push through the openings and the suture gets caught. Also, the tissue gets caught on the instrument, since the surface is very rough. As a result, tissue can be torn on the edges and will not have the ideal distance to the purse-string suture, which can cause the suture to tear when closing the instrument. Manual resection of tissue at the purse-string suture was necessary. There was no bleeding reported in excess of 500cc. The case was not extended by more than 30 minutes.
Patient Sequence No: 1, Text Type: D, B5
[20493082]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219930-2013-00706 |
| MDR Report Key | 3330979 |
| Report Source | 01,06 |
| Date Received | 2013-08-28 |
| Date of Report | 2013-08-08 |
| Date of Event | 2013-08-07 |
| Date Mfgr Received | 2013-08-08 |
| Date Added to Maude | 2013-09-09 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVENUE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN, FORMERLY US SURGICAL |
| Manufacturer Street | 60 MIDDLETOWN AVENUE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06473 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PURSTRING INSTRUMENT 215 |
| Generic Name | SURGICAL STAPLING DEVICE |
| Product Code | MFJ |
| Date Received | 2013-08-28 |
| Catalog Number | 020240 |
| Lot Number | B465 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN, FORMERLY US SURGICAL |
| Manufacturer Address | 60 MIDDLETOWN AVENUE NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-08-28 |