MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-08-20 for SURG PAT XRAY 1/2X1/2 80-1400 manufactured by Codman & Shurtleff, Inc..
[3830155]
The customer reported that the patties could not be seen under x-ray. The surgeon was conducting a routine x-ray and he knew the patties were there but they were not visible. Additional information from the customer stated when the surgeon also conducted an ap and lateral x-ray under fluoro with the c-arm the instrument was laid near the patty and the instrument was visible but the patties were not. An x-ray was also conducted with just a stack of patties in the package and they did not show up. There were no adverse consequences and no delay in surgery greater than 30 minutes.
Patient Sequence No: 1, Text Type: D, B5
[11019964]
Upon completion of the investigation, a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[32668613]
Upon completion of the investigation it was noted that the complaint samples were sent for testing from both lots. Testing was conducted per the requirements. All samples passed the requirements of the tests. The complaint could not be duplicated in the laboratory setting. The root cause could not be determined. Per the instructions for use, the document indicates that "this device is considered radiopaque in accordance with astm f640. The device may not be visible under all radiographic conditions. "? The size and position of the marker may impact radiopacity. In addition, adjacent structures may inhibit visibility. Multiple angles and modification of radiography parameters (e. G. Kevm mas) may be required to enhance visibility of the marker. " based on the results of this investigation no further action is required. Trends will be monitored for this and similar complaints. At the present time this complaint is closed.
Patient Sequence No: 1, Text Type: N, H10
[33355801]
4/17/14 we recently revised our mdr reporting procedures based on feedback from a recent fda audit that was conducted in 2013. Once the changes were made to the procedures, we conducted retrospective review of our product complaints and mdr files. The attached mdr report is being filed as result of those changes we made to our internal mdr reporting procedures. This report is being filed from malfunction to serious injury.
Patient Sequence No: 1, Text Type: N, H10
[33355802]
Customer reported that the patties could not be seen under x-ray. The surgeon was conducting a routine x-ray and knew the patties were there and noticed the patties were not visible. There were no adverse consequences and no delay in surgery greater than 30 min. Customer will be returning unused product for investigation. When the surgeon was performing the surgery he did a ap and lateral x-ray under fleuro with the c-arm. The doc layed the instrument near the pattie and the instrument was visable, but the patties were not. Also, the nurse also conducted an x-ray with just a stack of patties in the package and they did not show up. We recently revised our mdr reporting procedures based on feedback from a recent fda audit that was conducted in 2013. Once the changes were made to the procedures, we conducted retrospective review of our product complaints and mdr files. The attached mdr report is being filed as result of those changes we made to our internal mdr reporting procedures. This report is being filed from malfunction to serious injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2013-24433 |
| MDR Report Key | 3298608 |
| Report Source | 06 |
| Date Received | 2013-08-20 |
| Date of Event | 2013-08-01 |
| Date Mfgr Received | 2014-04-17 |
| Date Added to Maude | 2013-11-15 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283106 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURG PAT XRAY 1/2X1/2 |
| Generic Name | SURGICAL SPONGE |
| Product Code | FQA |
| Date Received | 2013-08-20 |
| Returned To Mfg | 2013-08-14 |
| Catalog Number | 80-1400 |
| Lot Number | 384003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-08-20 |