MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC UNKNOWN EEA; STAPLER, SURGICAL

Model Number UNKNOWN EEA

Device Problem Failure to Form Staple (2579)

Patient Problem No Code Available (3191)

Event Date 12/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Evaluation summary: post market vigilance (pmv) led an evaluation of one purstring device.The visual inspection and functional evaluation of the device had acceptable results.The reported condition was not confirmed.The product analysis concluded there were no device abnormalities that would have caused or contributed to the reported incident.Therefore, our investigation was unable to establish a relationship between the device and the reported incident.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.

Event Description

According to the reporter, during a high anterior resection, the anastomosis was performed with the device, however, mucosa was not completely resected.The surgeon used the device for suture and then performed anastomosis with the device.After that, they noted that mucosa was not completely resected.They requested evaluation of the psi.As the donuts were completed, the staple line was reinforced with additional suturing.The device was not reprocessed/re-sterilized prior to use as a new stapler fired over the original staple line or did additional tissue have to be transected to complete the procedure: as the donuts were completed, the staple line was reinforced with additional suturing; can you confirm that product is available and will be returned for evaluation: yes; was any reinforcement material used in conjunction with the stapling device: no.

• Brand Name: UNKNOWN EEA
• Type of Device: STAPLER, SURGICAL
• 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: 6365864
• MDR Text Key: 68593644
• Report Number: 2647580-2017-00191
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN EEA
• Device Catalogue Number: UNKNOWN EEA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention