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 06/25/2018

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 lobectomy, the surgeon tried to fire the device to pulmonary parenchymal, however at the first squeezing a crack sound was heard and could not fire the device.Replaced by a new handle and a new reload and the firing was completed.The surgeon said pulmonary parenchymal was not thick nor hard.No patient injury.

Manufacturer Narrative

Additional information: evaluation summary: post market vigilance (pmv) led an evaluation of one device.Initial visual inspection of the instrument noted no abnormalities.Functionally, the instrument was loaded with an 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: 1.Firing over tissue that is beyond the recommended thickness range.2.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."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: 7682477
• MDR Text Key: 113953364
• Report Number: 2647580-2018-03461
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884523003536
• UDI-Public: 10884523003536
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

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 Model Number: EGIAUSHORT
• Device Catalogue Number: EGIAUSHORT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2018
• Initial Date FDA Received: 07/12/2018
• Supplement Dates Manufacturer Received: 08/01/2018; 08/08/2018
• Supplement Dates FDA Received: 08/15/2018; 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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