MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-03-27 for STANDARD NET 230L 10 PACK 00230A manufactured by Conmed Corporation.
[140004395]
Received 6, 00230a. We were able to confirm 1 net out of the 6 nets was ruptured. The lot number and catalog number were both verified. During our visual inspection of the ruptured retrieval net, the netting had appeared to be discolored and was bunching onto itself. The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product. The product released for distribution was found to have met all specifications prior to shipment. This is the only complaint for this lot number and failure mode within the past two years. A two-year review of complaint history revealed there has been a total of 10 complaints, regarding 16 devices, for this device family and failure mode. During this same time frame (b)(4) devices have been manufactured and shipped worldwide. Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4). Per the instructions for use, the user is advised the following: warning: do not use this device if there is any detectable handling or shipping damage. This device is not recommended for the capture of sharp objects. When retrieving objects through the esophagus, be sure to keep gentle tension on the device handle to avoid dislodgement, loss of object and/or aspiration into the trachea. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[140004396]
The customer reported that 00230a, standard net 230l 10 pack, device was being used during an egd (esophagogastroduodenoscopy) with dilation on (b)(6) 2019 when "the device ruptured upon removal at or around the top of the esophagus which was concerning for the aspiration of the net and the foreign body. After determining the foreign body migrated back to the stomach, a second net and (second) attempt was made but the patient was not tolerating the procedure well and it was aborted. The patient did not have any sign of aspiration or breathing difficulty". Further assessment from the reporter found that the reason the patient was not tolerating the procedure well was not directly due to the device but instead the patient was coughing and becoming restless; however, the patient was stable. When the device was removed from the scope a hole in the net was found. The foreign body may not have been "smooth"; however, it was not considered "sharp". This event caused ~5-minute delay. It was felt by the reporter that there were no fragments from the device; therefore, there were no fragments to retrieve. There was no report of medical intervention or extended hospital stay for the patient. It is stated by the reporter that the foreign body that migrated to the stomach "will pass naturally". This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320894-2019-00080 |
| MDR Report Key | 8455983 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-03-27 |
| Date of Report | 2019-03-27 |
| Date of Event | 2019-03-07 |
| Date Mfgr Received | 2019-03-07 |
| Device Manufacturer Date | 2018-10-29 |
| Date Added to Maude | 2019-03-27 |
| 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 | MR. JOHN BERGA |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995358 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STANDARD NET 230L 10 PACK |
| Generic Name | SNARE, NON-ELECTRICAL |
| Product Code | FGX |
| Date Received | 2019-03-27 |
| Returned To Mfg | 2019-03-14 |
| Catalog Number | 00230A |
| Lot Number | 201810291 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH ROAD UTICA NY 135025994 US 135025994 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-27 |