MAUDE Adverse Event Report: TELEFLEX MEDICAL CAPIO SUTURES

Catalog Number OEM UNKNOWN

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The device history review could not be conducted since the lot number nor product code was provided.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the bullet tip broke from the suture when shooting the bullet through the ligament.The physician had to bend the capio device open to make sure the bullet tip had not fallen into the patient which it had not.They opened a new device and could proceed with the operation.There was no patient injury.

• Brand Name: CAPIO SUTURES
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 9437826
• MDR Text Key: 191740991
• Report Number: 3004365956-2019-00352
• Device Sequence Number: 1
• Product Code: PWI
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: OEM UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2019
• 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: N
• Patient Sequence Number: 1