MAUDE Adverse Event Report: CONMED DRY-DOC CANNULA WITH DISPOSABLE OBTURATOR 8.0 X 85MM

Catalog Number C7368

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 09/07/2016

Event Type  Injury  

Manufacturer Narrative

The reported device was not returned to conmed for evaluation nor was photographic evidence provided.The complaint is unable to be verified.The surgeon was reported to have modified the device by removing the ring from the sleeve in order to advance the cannula deeper within the joint.This allowed the sleeve to detach from the device.A review of the manufacturing documents was unable to be performed as the lot number was not provided.A two-year historical complaint review identified one similar report for this device family.In that same timeframe, (b)(4).A risk analysis was performed and found to be acceptable and in alignment with current risk documents.The instructions for use warn the user of the following.-do not re-sterilize.Single use only.-to avoid damaging seals and excessive leakage, do not use with devices larger than the specified cannula diameter.The instructions for use direct the user of the following steps.-remove items from sterile package.-place obturator into the dry-doc cannula.-pull back the flexible outer sleeve to allow pleats are smooth.-advance the cannula into the joint.Once in the correct position release the outer sleeve to allow the pleats to engage the capsule, muscle, skin, etc.This will prevent the cannula from backing out of the joint.-properly discard the cannula after use.This incident type will continue to be monitored through the complaint system to assure patient safety.

Event Description

A customer reported a patient injury on mw5073496.It was reported that a patient underwent an arthroscopic surgery for chronic shoulder instability.Due to the patient's large habitus, the procedure required a surgical cannula be modified in order to reach the joint.The user removed a plastic ring on the cannula so it could extend farther into the surgical site.Upon removal, the outer sleeve of the cannula has detached and was retained in the soft tissue.This was not noticed by the doctor until 3 months post surgery.On (b)(6) 2016 this retained component was removed during a second procedure.This report is raised on the basis of a reported injury due to a device component being retained in the patient.

• Brand Name: DRY-DOC CANNULA WITH DISPOSABLE OBTURATOR 8.0 X 85MM
• Type of Device: CANNULA
• Manufacturer (Section D): CONMED; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502
• Manufacturer Contact: lindsey sheppard ; 525 french road; utica, NY 13502 ; 7273995209
• MDR Report Key: 7162168
• MDR Text Key: 96331108
• Report Number: 1017294-2017-00152
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C7368
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 01/03/2018
• 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: Initial
• Patient Sequence Number: 1