MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2015-08-18 for SURGICAL PATTIE, 1/2 X 1/2 80-1400 manufactured by Codman & Shurtleff, Inc..
[23286629]
(b)(4). Upon completion of the investigation a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[23286630]
A pack of #801400 had only 9 pc which should be 10 pc. The nurse in charge requested for an official letter to explain why this happened. She wants to know patties is packed by machine or human. Official customer letter is requested. Thanks. 8/13/15 per affiliate, no delay over 30 minutes.
Patient Sequence No: 1, Text Type: D, B5
[33368629]
Upon completion of the investigation, it was noted that the patties are produced in a fully automated machine with very little human intervention. Patties which have been produced are inspected using a computer vision inspection throughout the process. The final step of the process is to place the patties on the card, which is done automatically by the machine. There is a vision system which then takes a picture of the 10 strings on the card and only allows it to pass if there were 10 strings found. The automated machine used to produce this product uses a vision inspection system to 'count' the number of patties on the card. The system is very robust at finding any missing patties. Therefore the most probable root cause lies in operator error, this however could not be determined. Automated pattie operators are trained not to rework any product to eliminate this risk of miscounts. A tcr was opened to retrain and communicate this complaint to our operators that had worked on the lots in question. Another potential location could be at the packaging step, since operators will rewrap loose strings before packaging them product. Patties can become loose when the operators are handling the cards during packaging. A tcr was opened to retrain and communicate this complaint to our operators that had worked on the lots in question. A trending evaluation was done and no trend was found at this time. We have seen very few complaints for this particular failure mode. We will continue to monitor customer complaints to ensure this is not a developing trend which will require corrective action. Based on the results of this investigation no further action is required. At the present time this complaint is closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2015-10473 |
| MDR Report Key | 5010669 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-08-18 |
| Date of Event | 2015-07-25 |
| Date Mfgr Received | 2015-08-25 |
| Date Added to Maude | 2015-08-18 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR JAMES KENNEY |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088282726 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGICAL PATTIE, 1/2 X 1/2 |
| Generic Name | SURGICAL SPONGE |
| Product Code | HBN |
| Date Received | 2015-08-18 |
| Returned To Mfg | 2015-08-14 |
| Catalog Number | 80-1400 |
| Lot Number | 244040 |
| 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 | 2015-08-18 |