MAUDE Adverse Event Report: US SURGICAL PUERTO RICO UNKNOWN SURGICLIP; CLIP, IMPLANTABLE

Model Number UNKNOWN SURGICLIP

Device Problems Failure to Align (2522); Material Deformation (2976); Mechanics Altered (2984)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2021

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 an axillary dissection, the surgeon was able to squeeze the handle, when the doctor applied the clip, the jaws and the clips at the end crossed of the 3 clip appliers.The clips were noted to be malformed.Moreover the applicator stopped before the end even if there were still clips, for the other it was impossible to remove the applicator once the clip was installed.Another device was used to resolve the issue.There was no patient injury.

• Brand Name: UNKNOWN SURGICLIP
• Type of Device: CLIP, 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12322513
• MDR Text Key: 266574752
• Report Number: 2647580-2021-02770
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN SURGICLIP
• Device Catalogue Number: UNKNOWN SURGICLIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2021
• 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