MAUDE Adverse Event Report: CONMED CORPORATION 5MM X 73MM CLEAR FLEXIBLE CANNULA THREADED; ACCESSORIES, ARTHROSCOPIC

Catalog Number C7312

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

At time of filing, although expected, the reported device has not been returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

Conmed received a report from the customer documenting issues with the.5mm x 73mm clear flexible cannula threaded, item # c7312, lot 994150, that occurred on (b)(6) 2019 at (b)(6) hospital in (b)(6).It was noted that "during acromioplasty surgery, seal was detached from a cannula and left inside of a patient body in the middle of inserting a shaver.As soon as the surgeon found it, he removed the left seal using a grasper forceps.Surgery was completed successfully using another c7312 with a 5-minute delay ".The information received noted the patient was a (b)(6) female and there was no impact or injury to her.Although requested, no additional information was made available.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence (fragmentation falling in the patient).

• Brand Name: 5MM X 73MM CLEAR FLEXIBLE CANNULA THREADED
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo FL 33773 4908
• Manufacturer (Section G): CONMED CORPORATION; 11311 concept blvd; largo FL 33773 4908
• Manufacturer Contact: tracey weiselbenton ; 11311 concept blvd; largo, FL 33773-4908 ; 7273995557
• MDR Report Key: 9450231
• MDR Text Key: 219199517
• Report Number: 1017294-2019-00158
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: EXEMPT
• 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: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C7312
• Device Lot Number: 994150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR