MAUDE Adverse Event Report: STRYKER ENDOSCOPY 6.5 CANNULA; ACCESSORIES, ARTHROSCOPIC

Catalog Number 377-031-650

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/17/2020

Event Type  malfunction  

Event Description

At the end of a left knee arthroscopy, the surgical tech inspected the 6.5 cannula of the trocar and did not see the o-ring inside.It was noted that the o-ring was there prior to the start of the case.The surgeon was notified of missing o-ring & an x-ray was ordered.While waiting for x-ray to arrive, the stryker rep also inspected the cannula and discovered the o-ring within the cannula but pushed out of place.The surgical tech confirmed that she also could visualize the o-ring.X-ray was cancelled.The surgeon noted that the o-ring is not secure and fails.During this surgery on the first attempt, the o-ring popped out before getting started.The next cannula leaked throughout the procedure.The surgical tech could not find the o-ring after the case leading to concern about a missing piece of equipment.Eventually the o-ring was found, curled up inside the cannula, but dislodged from its proper location.Manufacturer response for trocar 6.5, 6.5 cannula (per site reporter).Manufacturer's representative is aware of ongoing problem with trocar and o-ring.

• Brand Name: 6.5 CANNULA
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY; 5900 optical court; san jose CA 95138
• MDR Report Key: 10337703
• MDR Text Key: 200798607
• Report Number: 10337703
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/20/2020

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: No Information
• Device Catalogue Number: 377-031-650
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24090 DA