MAUDE Adverse Event Report: CONMED DRY-DOC CANNULA WITH DISPOSABLE OBTURATOR ; SURGICAL CANNULA

Catalog Number C7368

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/07/2016

Event Type  Injury  

Event Description

On (b)(6) 2016, the patient underwent an arthroscopic surgery for chronic shoulder instability.Due to the patient's large habitus, the procedure required that the surgical cannula (dry-doc cannula with disposable obturator) be modified in order to reach the joint.The modification included removing a plastic ring on the cannula so that it could extend farther.When the cannula was removed, the outer sleeve of the cannulas was retained in the soft tissues.

• Brand Name: DRY-DOC CANNULA WITH DISPOSABLE OBTURATOR
• Type of Device: SURGICAL CANNULA
• Manufacturer (Section D): CONMED; utica NY 13502
• MDR Report Key: 7049978
• MDR Text Key: 92776124
• Report Number: MW5073496
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2021
• Device Catalogue Number: C7368
• Device Lot Number: 783324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1