MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC ENDO UNIVERSAL*65 12MM INSTR.W/4.8MM DLU; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 173052

Device Problem Failure to Form Staple (2579)

Patient Problem Obstruction/Occlusion (2422)

Event Date 09/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

To repair the internal herniation, one endouniversal stapler was used to close the meso, as usual during this intervention.Afterwards, the patient was found with an obstruction of the small intestines.At reoperation, surgeon discovered that this bowel obstruction was caused by one of the staples that was not totally closed, and the bowel was hooked on it.The current patient status is ok.Additional information has been requested but not yet received.

Manufacturer Narrative

(b)(4).

Event Description

Per additional information received, according to the reporter, to correct the patient's obstruction, relaparoscopy was performed two days post-op.The stapler was also removed, which grabbed a piece of mesentery because it was not fully closed.The staple line was incomplete in the initial procedure.The original intended procedure was closing internal hernia ports and a laparoscopic cholecystectomy.The last known patient status was good, fully recovered.

• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer (Section G): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6033933
• MDR Text Key: 57628610
• Report Number: 2647580-2016-00824
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K912097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 173052
• Device Catalogue Number: 173052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR