MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN TRI-STAPLE 2.0; STAPLE, IMPLANTABLE

Model Number	SIGTRS45AXT
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic conducted an investigation based upon all information received.The device was available for evaluation.No information regarding the specific customer issue that occurred with the device was available.Upon examination of the sample, it was found that the reload was partially fired to the cut line, and the anvil clamping mechanism was deformed.Functional testing required the interlock to be overridden and the reload was applied to test media.The reload interlock was tested and found to function properly.The product analysis noted evidence that the device was not used as intended.Deformed anvil clamping mechanism may occur either by firing over tissue that is beyond the recommended thickness range, or by 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 manufacturing records for each device are thoroif information is provided in the future, a supplemental report will be issued.Ughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: 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.
Event or Problem Description
According to the reporter, during a laparoscopic gastric sleeve procedure, not all clamps were triggered when the reload was fired.Surgeon replaced the reload to resolve the issue.No patient injury.Medtronic's initial evaluation of the incident is that the device was found to be partially fired.Evaluation of the device¿s condition revealed that it had been applied on tissue beyond the indicated range.

• Brand Name: TRI-STAPLE 2.0
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 12665953
• Report Number: 1219930-2021-04363
• Device Sequence Number: 11070579
• Product Code: GDW
• UDI-Device Identifier: 10884521543621
• UDI-Public: 10884521543621
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K160176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SIGTRS45AXT
• Device Catalogue Number: SIGTRS45AXT
• Device Lot Number: 0036019NH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR