MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-11-22 for DISPOSABLE PURSTRING* 65 INSTRUMENT 020242 manufactured by Covidien, Formerly Ussc Puerto Rico Inc.
[60742814]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[60742815]
According to the reporter, during a sigmoidectomy procedure, the suture broke. The procedure was completed with manual suturing. After the purstring was used, surgeon tried to fix an anvil with the suture from the purstring with no excessive force, but the suture broke easily. The tissue was resected by 5 mm to perform another purse string. The status of the patient is no problem.
Patient Sequence No: 1, Text Type: D, B5
[62858520]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[76837111]
Post market vigilance (pmv) led an evaluation of one photo and a device. It was observed, under magnification, that the suture appeared to have split under tension. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. Analysis concluded there were no assembly component related failures. Should new information become available, the file will be re-opened and the investigation summary amended as appropriate. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647580-2016-00985 |
| MDR Report Key | 6122710 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-11-22 |
| Date of Report | 2017-05-10 |
| Date of Event | 2016-10-17 |
| Date Mfgr Received | 2017-05-10 |
| Device Manufacturer Date | 2012-03-01 |
| Date Added to Maude | 2016-11-22 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN, FORMERLY USSC PUERTO RICO INC |
| 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 | DISPOSABLE PURSTRING* 65 INSTRUMENT |
| Generic Name | CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GDJ |
| Date Received | 2016-11-22 |
| Returned To Mfg | 2016-12-02 |
| Model Number | 020242 |
| Catalog Number | 020242 |
| Lot Number | P2C0174X |
| Device Expiration Date | 2017-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN, FORMERLY USSC PUERTO RICO INC |
| Manufacturer Address | BUILDING 911-67 SABANETAS INDUSTRIAL PARK PONCE PR 00731 US 00731 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-11-22 |