MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-07-22 for PROXIMATE HCS HEMORR CIR STAPL PPH01 manufactured by Ethicon Endo-surgery, Inc.(cincinnati).
[17494028]
It was reported that during an ods procedure, cutting and stapling was not complete; malformed staples, and some of the staples were stuck halfway in the device. Overstitched by hand to complete the procedure. Experienced postoperative bleeding and had to reoperate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1527736-2005-03226 |
| MDR Report Key | 622322 |
| Report Source | 07 |
| Date Received | 2005-07-22 |
| Date of Report | 2005-06-28 |
| Date Mfgr Received | 2005-06-28 |
| Device Manufacturer Date | 2004-09-01 |
| Date Added to Maude | 2005-07-26 |
| 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 | 0 |
| Manufacturer Contact | GARY LEBLANC |
| Manufacturer Street | 4545 CREEK ROAD |
| Manufacturer City | CINCINNATI OH 45242 |
| Manufacturer Country | US |
| Manufacturer Postal | 45242 |
| Manufacturer Phone | 5133378582 |
| Manufacturer G1 | ETHICON ENDO SURGERY, INC (TORRES) |
| Manufacturer Street | AVENIDA DE LAS TORRES 7125 PARQUE |
| Manufacturer City | CIUDAD JUAREZ |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROXIMATE HCS HEMORR CIR STAPL |
| Generic Name | PPH SET |
| Product Code | KDG |
| Date Received | 2005-07-22 |
| Returned To Mfg | 2005-07-28 |
| Model Number | NA |
| Catalog Number | PPH01 |
| Lot Number | NI |
| ID Number | BATCH # V5CY2T |
| Device Expiration Date | 2009-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 611971 |
| Manufacturer | ETHICON ENDO-SURGERY, INC.(CINCINNATI) |
| Manufacturer Address | * CINCINNATI OH * US |
| Baseline Brand Name | PROXIMATE HCS HEMMORR CIR STAPL |
| Baseline Generic Name | PROXIMATE HSC (PPH) SET |
| Baseline Model No | NA |
| Baseline Catalog No | PPH01 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-07-22 |