MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2017-02-03 for DISPOSABLE PURSTRING* 65 INSTRUMENT 020242 manufactured by Covidien, Formerly Ussc Puerto Rico Inc.
[66498696]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[66498697]
According to the reporter, during a hemicolectomy. The stapler failed as it would not lock and it misfired the sutures. He says that when he closed the purstring around the bowel that after he fired it the staple line seemed loose to him, complete but loose. Another device was used without further consequences. No medical intervention required. Patient current status reported as good, at home. The device will not be returned for evaluation, it was discarded by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2647580-2017-00122 |
| MDR Report Key | 6300781 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2017-02-03 |
| Date of Report | 2016-07-11 |
| Date of Event | 2016-07-05 |
| Date Mfgr Received | 2016-07-11 |
| Device Manufacturer Date | 2015-01-01 |
| Date Added to Maude | 2017-02-03 |
| 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 | 2017-02-03 |
| Model Number | 020242 |
| Catalog Number | 020242 |
| Lot Number | P5C0105X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-02-03 |