MAUDE Adverse Event Report: ADVANCED MEDICAL DESIGN CO., LTD. SCOPE CLEANOR; SCOPE + TROCAR CLEANING DEVICE

Model Number SC-01

Device Problem Collapse (1099)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2017

Event Type  malfunction  

Manufacturer Narrative

Possible failure situation which causes the customer complaint according to the information given from orc, the trocar was introduced very shallowly.The end of trocar was placed between the peritoneum and the facial muscle, instead of approaching to the abdominal cavity.Therefore, when the physician uses the trocar cleanor to clean the trocar, there is a possible situation that the end of swab head was stuck between the trocar and the peritoneum/facial muscle, then the trocar cleanor was removed from the trocar.The sponge of the trocar cleanor should bear a residual pull force during the removal step of the trocar cleanor from the trocar.That is the main possible reason that the swab of the trocar cleanor was cut and approximate 3/4 sponge left in the peritoneum/facial muscle of the patient.Summary: according to the previous analysis, the pull strength of trocar cleanor meets the product specification >= 1 kgf) and the product specification which established, in the beginning, could meet the clinical operation situation purpose.The possible failure situation of the customer complaint is that the end of swab head was stuck between the trocar and the peritoneum/facial muscle, then the trocar cleanor was removed from the trocar and residual pull force of the trocar cleanor exists.Since the trocar should introduce into the abdomen cavity of the patient first, then the trocar cleanor should be used to clean the blood which left on the inner surface of the trocar.If the trocar does not pass through the abdomen cavity, it may cause that the trocar cleanor would touch the peritoneum/facial muscle.The continued side effect may cause the failure situation.

Event Description

Due to a 6-liter ovarian cyst, the initial trocar we 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 x-rays, they completed the ovarian cyst procedure and then performed a small laparotomy incision to further investigate for the foam piece.They found it between the peritoneum and the facial muscle.

• Brand Name: SCOPE CLEANOR
• Type of Device: SCOPE + TROCAR CLEANING DEVICE
• Manufacturer (Section D): ADVANCED MEDICAL DESIGN CO., LTD.; 4-5f., no. 29, wuquan 5th rd.,; wugu dist.,; new taipei city, 248 ; TW 248
• Manufacturer (Section G): ADVANCED MEDICAL DESIGN CO., LTD.; 4-5f., no. 29, wuquan 5th rd.,; wugu dist.; new taipei city, 248 ; TW 248
• Manufacturer Contact: jason chen ; 4-5f., no. 29, wuquan 5th rd.,; wugu dist.; new taipei city, 248 ; TW 248
• MDR Report Key: 17582906
• MDR Text Key: 321530808
• Report Number: 3010437008-2023-00003
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/20/2023

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: SC-01
• Device Catalogue Number: SC-01
• Device Lot Number: 1611054
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2017
• Initial Date FDA Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2016
• 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): Other