MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-12-20 for ENDO GIA* TRI-STAPLE RR 60MM M/T RELOAD EGIATRS60AMT manufactured by Covidien, Formerly Us Surgical A Divison.
[62858406]
(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
[62858407]
According to the reporter, during a laparoscopic sleeve gastrectomy the stapler laid down 10mm of staples and stopped. Surgeon was unable to advance it further. He re-tracked the stapling mechanism and cut the buttress material in order to remove the stapler. The staple line was completed successfully with another device. Current patient status is good. Ended colostomy, formal laparotomy, re-operation etc. There was no unanticipated tissue loss. There was no irreversible tissue damage. There was no unanticipated extension of the incision by more than one inch. There was no unanticipated blood loss of 500cc or more. Surgery time was not delayed by more than 30 minutes. No device fragment or component fell into the patient's cavity. There was no device fragment left in patient's cavity. Additional information requested via email to (b)(4). Can you confirm that product is available and will be returned for evaluation? Please provide the serial number and product id of the idrive handle used. Could you please provide the udi# (see attached, red box) for the handle used in the procedure? Please provide the serial number and product id of the idrive adapter used. What is the udi# for the adapter used in the procedure? What was the device sterilization method? (eto or autoclave). (1). What type of cleaning was used on this device? (manual or auto-washer). Please describe the status of the following lights: (1). Status indicators: (2). 5 white lights: (3). Handle indicator: (4). Adapter indicator: (5). Reload indicator: what is the lot number for the reload used with this stapler? Could you please provide the udi# (see attached, red box) for the reload used in the procedure? Should the customer(s) be notified of product analysis results, if available? (customer response letter).
Patient Sequence No: 1, Text Type: D, B5
[87034023]
Evaluation summary: post market vigilance (pmv) led an evaluation of one device. Visual inspection of the cartridge revealed that the reload was partially fired to the 3. 5cm line. Microscopic evaluation noted that the reload had damage to the cutting edge of the knife blade. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. Analysis concluded there were no assembly component related failures. Replication of the damaged knife blade may occur when an obstacle has been incorporated in the jaws during application. The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident. Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219930-2016-01381 |
| MDR Report Key | 6190142 |
| Report Source | USER FACILITY |
| Date Received | 2016-12-20 |
| Date of Report | 2017-05-24 |
| Date of Event | 2016-11-29 |
| Date Mfgr Received | 2017-05-24 |
| Date Added to Maude | 2016-12-20 |
| 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 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 M/T RELOAD |
| Generic Name | MESH, SURGICAL, DEPLOYER |
| Product Code | ORQ |
| Date Received | 2016-12-20 |
| Returned To Mfg | 2017-05-04 |
| Model Number | EGIATRS60AMT |
| Catalog Number | EGIATRS60AMT |
| 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 | 2016-12-20 |