MAUDE Adverse Event Report: ADVANCED MEDICAL DESIGN SCOPE CLEANOR; LAPAROSCOPIC ACCESSORIES, GYNECOLOGICAL

Model Number SC01

Device Problems Detachment Of Device Component (1104); Torn Material (3024)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/02/2017

Event Type  malfunction  

Manufacturer Narrative

Device not returned to the manufacturer.

Event Description

During the removal of a 6l ovarian cyst, the initial trocar was placed very shallowly.After the trocar was removed from the cannula, the 5/8mm swab was used to clean the cannula prior to inserting the scope.After this was done, the staff immediately noticed that approximately 3/4ths of the foam tip had torn loose.The scope was inserted and the surgeon began to look for the missing foam piece.After approximately 90 minutes of searching and xrays, they completed the ovarian cyst procedure and found the foam tip it between the peritoneum and the facial muscle.

• Brand Name: SCOPE CLEANOR
• Type of Device: LAPAROSCOPIC ACCESSORIES, GYNECOLOGICAL
• Manufacturer (Section D): ADVANCED MEDICAL DESIGN; 5f., no.3, wugong 5th rd; xinzhuang dist 24888
• Manufacturer Contact: kelly spurge ; 1625 south tacoma way; tacoma, WA
• MDR Report Key: 6676185
• MDR Text Key: 78980646
• Report Number: 3010570913-2017-00001
• Device Sequence Number: 1
• Product Code: NWV
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/14/2017,06/28/2017

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 Expiration Date: 06/30/2019
• Device Model Number: SC01
• Device Lot Number: 1611054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2017
• Device Age: 15 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/28/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/25/2016
• 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
• Patient Outcome(s): Required Intervention