MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO GIA ULTRA; STAPLE, IMPLANTABLE

Model Number EGIAUSHORT

Device Problems Crack (1135); Failure to Fire (2610); Noise, Audible (3273); Firing Problem (4011)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter during a laparoscopic video-assisted thoracoscopic surgery (vats), when the device was being applied to lung tissue, the stapler was not able to fire.The surgeon was not able to squeeze the handle.The stapler and cartridge was used to resect a segment of lung.When engaged to staple the tissue, the whole thing cracked.The cutting mechanism was not used.It was replaced by new device to complete the case.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Initial visual inspection of the instrument noted no abnormalities.Fun ctionally, the instrument was loaded with articulating vascular/medium reload.During testing of the instruments, a skip was noted in the units firing stroke after closure of the reload jaws.An access hole was cut into the instrument body for visualization of the firing rack.This examination noted sheared teeth on the firing rack.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 sheared teeth on the firing rack 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."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 misuse of the product which would have caused or contributed to the reported incident.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO GIA ULTRA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7738828
• MDR Text Key: 115771801
• Report Number: 2647580-2018-03850
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884523003536
• UDI-Public: 10884523003536
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K111825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: EGIAUSHORT
• Device Catalogue Number: EGIAUSHORT
• Device Lot Number: P8D1668X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/17/2018
• Initial Date FDA Received: 08/01/2018
• Supplement Dates Manufacturer Received: 09/07/2018; 08/08/2018
• Supplement Dates FDA Received: 09/27/2018; 10/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1