MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-12-09 for ENDO GIA* TRI-STAPLE RR 60MM ET RELOAD EGIATRS60AXT manufactured by Covidien, Formerly Us Surgical A Divison.
[61920987]
(b)(4). Additional attempts to obtain information and the device have been made. A supplemental report will be submitted with new details if they become available.
Patient Sequence No: 1, Text Type: N, H10
[61920988]
According to the reporter, during a laparoscopic sleeve gastrectomy, involving the stomach, the reload only fired part way and stopped and locked out with the powered stapler. A new reload was used and fired completely. The last known patient status is fine. There was unanticipated tissue loss as a result of this problem.
Patient Sequence No: 1, Text Type: D, B5
[64149624]
(b)(4). Additional information: describe event or problem.
Patient Sequence No: 1, Text Type: N, H10
[64149745]
Per additional information received, according to the reporter, they had to staple around the first staple line. They were able to finally release it from the tissue.
Patient Sequence No: 1, Text Type: D, B5
[66699951]
(b)(4). Stapler handle was not returned.
Patient Sequence No: 1, Text Type: N, H10
[69355170]
(b)(4). Post market vigilance (pmv) led an evaluation of two devices visual inspection of the reloads noted that both were partially fired. Functional evaluation noted that one reload had a deformed anvil clamping mechanism. Both reloads fired all remaining staples without issue. Product analysis suggests the product was used in a surgical procedure. Replication of the deformed anvil clamping mechanism may occur when the application is over tissue that is beyond the recommended thickness range or when application with an obstacle incorporated in the jaws. In any of these circumstances, it will become increasingly difficult to actuate the firing handle and the instrument return knobs will be difficult to retract. In addition, staples may not form properly and tissue may not be fully transected. The information booklet which accompanies each product shipment offers the following as a warning and precaution-preoperative radiotherapy may result in changes to tissue. These changes may, for example, cause the tissue thickness to exceed the indicated range thickness for the staple size. Careful consideration should be given to any pre-surgical treatment the patient may have undergone and in corresponding selection of staple size. A review of the device history record indicates this devices lot number was released meeting all quality release specifications at the time of manufacture. No enhancements or improvements were generated for the reported condition. The product analysis concluded there were no device abnormalities that would have caused or contributed to the reported incident. Should new information become available, the file will be re-opened and reassessed at that time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219930-2016-01321 |
| MDR Report Key | 6159432 |
| Report Source | USER FACILITY |
| Date Received | 2016-12-09 |
| Date of Report | 2016-11-14 |
| Date of Event | 2016-11-14 |
| Date Mfgr Received | 2017-02-21 |
| Date Added to Maude | 2016-12-09 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN, FORMERLY US SURGICAL A DIVISON |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06473 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDO GIA* TRI-STAPLE RR 60MM ET RELOAD |
| Generic Name | MESH, SURGICAL, DEPLOYER |
| Product Code | ORQ |
| Date Received | 2016-12-09 |
| Returned To Mfg | 2017-01-10 |
| Model Number | EGIATRS60AXT |
| Catalog Number | EGIATRS60AXT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN, FORMERLY US SURGICAL A DIVISON |
| Manufacturer Address | 60 MIDDLETOWN AVE NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-09 |