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 2020-03-31 for ENDO GIA EGIATRS60AMT manufactured by Covidien Lp Llc North Haven.
[185810825]
Evaluation summary: post market vigilance (pmv) led an evaluation of one device. Visual inspection of the cartridge revealed that the reload was partially fired with the interlock engaged. The jaws were open. Staple pushers were visible at the 4cm cut line. The clamping mechanism was deformed. Staple pushers were flush with the cartridge. Functionally the reload was loaded into a post market vigilance instrument, the interlock was overridden, and the reload was cycled without hesitation and was applied to test media with proper staple placement and media transection. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. Replication of the deformed clamping mechanism and partially flush staple pushers may occur under the following conditions. 1. Application over tissue that is beyond the recommended thickness range. 2. 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. "1. 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. The root cause of the observed damage was due to the product not being used as intended which caused or contributed to the reported condition. No further actions have been deemed necessary at this time. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185810826]
According to the reporter, when stapling the first staple line during a laparoscopic gastric sleeve resection the stapler did fire however, the device locked on tissue and there was an incomplete staple line proximally. The reinforced material from the reload was cut then the reload was removed and replaced to resolve the issue in order to complete the case. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2020-01459 |
| MDR Report Key | 9905479 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-03-12 |
| Date Added to Maude | 2020-03-31 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA HERNANDEZ |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | COVIDIEN LP LLC NORTH HAVEN |
| Manufacturer Street | 195 MCDERMOTT RD |
| 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 |
| Generic Name | STAPLE, IMPLANTABLE |
| Product Code | GDW |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-02-26 |
| Model Number | EGIATRS60AMT |
| Catalog Number | EGIATRS60AMT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP LLC NORTH HAVEN |
| Manufacturer Address | 195 MCDERMOTT RD NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |