MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN ENDO GIA; STAPLE, IMPLANTABLE

Model Number	EGIATRS45AXT
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, at the first firing of a wedge segmental resection procedure, the reinforced reload could be used normally, but at the second firing, there was a crack sound and the device could only fire until halfway.Oozing bleeding occurred as a result of the issue.Although the handle and the reload were replaced many times, the same event occurred, so finally the suture was completed by hand.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of four devices.Visual inspection of the cartridges noted that the first and second reloads had a full complement of staples.The third and fourth reloads were received partially fired and the anvil clamping mechanisms were deformed.Functional testing of the reloads found no abnormalities.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 anvil clamping mechanism may occur in any of the following circumstances: firing over tissue that is beyond the recommended thickness range.Firing with an obstacle incorporated in the jaws.In either 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.The root cause of the observed damage was misuse of the product 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.

• Brand Name: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8037543
• Report Number: 1219930-2018-05839
• Device Sequence Number: 1463758
• Product Code: GDW
• UDI-Device Identifier: 10884521190993
• UDI-Public: 10884521190993
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133938
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: EGIATRS45AXT
• Device Catalogue Number: EGIATRS45AXT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention