MAUDE Adverse Event Report: STRYKER 10MM, 0 DEGREE RIGID SCOPE; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Device Problem Component Missing (2306)

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

Event Date 08/13/2020

Event Type  malfunction  

Event Description

Elderly male may have a lens from a 10 mm scope in the gallbladder following a laparoscopic cholecystectomy.X-ray of patient is negative.

• Brand Name: 10MM, 0 DEGREE RIGID SCOPE
• Type of Device: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): STRYKER; 5900 optical ct; san jose CA 95138
• MDR Report Key: 10441749
• MDR Text Key: 204015344
• Report Number: 10441749
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/14/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2020
• Type of Device Usage: N
• Patient Sequence Number: 1