MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-15 for PURSTRING 020242 manufactured by Covidien Lp.
[136275204]
The dr. Had the purse string stapler device on the bowel and fired it. The plastic notch broke off and flung on the patient, not in the patient. The broken stapler and notch were saved and sent to clinical engineering. A new stapler was used to complete the procedure with no harm to the patient. Images of the broken stapler were obtained and this device will be returned to the manufacturer for failure analysis. Manufacturer response for clamp, surgical, general plastic surgery, purstring (per site reporter). The device will be returned for failure analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8343439 |
| MDR Report Key | 8343439 |
| Date Received | 2019-02-15 |
| Date of Report | 2019-02-07 |
| Date of Event | 2019-01-23 |
| Report Date | 2019-02-07 |
| Date Reported to FDA | 2019-02-07 |
| Date Reported to Mfgr | 2019-02-15 |
| Date Added to Maude | 2019-02-15 |
| 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 | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | PURSTRING |
| Generic Name | CLAMP, SURGICAL, GENERAL PLASTIC SURGERY |
| Product Code | GDJ |
| Date Received | 2019-02-15 |
| Model Number | 020242 |
| Catalog Number | 020242 |
| Lot Number | P8J1494RX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP |
| Manufacturer Address | 15 HAMPSHIRE ST. MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-15 |