MAUDE Adverse Event Report: CIPHER SURGICAL LIMITED OPCLEAR PROCEDURE DISPOSABLE KIT; endoscopic irrigation/suction system

Model Number CS-10-00-315

Device Problem Nonstandard Device (1420)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

During internal testing by cipher, it was found that upon application, the disposable sheaths were cracking and causing shattering in some cases due to a manufacturing defect.Not all devices in the batch are aff ected.Device was not used on a patient.The below product variants and associated batches are affected: cs-10-00-315: a48/3/0041/22e,a02/4/0041/23e, a18/6/0041/23e cs-10-30-315:a11/6/0041/23f, a38/4/0041/22f, a05/5/0041/23f cs-10-00-330: a15/3/0041/23g cs-10-30-330:a09/3/0041/23h, a50/6/0041/22h there is a possibility that the fragments could enter the patient abdominal cavity during product use.There are currently no reports of adverse incidents from this defect in any market that the product is available.The affected devices have only been used for sales evaluation with patients in the usa.This product has been under the control of cipher sales staff.There is no affected product in hospitals.Although initial testing was carried out on the 27-feb-24 which we have put as the date of the event, there was no decision on that date to determine if the decision was to report as a serious incident.Further testing was done on the on (b)(6)2024 that gave information to support and decision to report was documented on the on (b)(6)2024 we have been trying to submit this report since the last 4 days through the esg portal but were unable to do so due to technical issues encountered in the system.We had to contact the support help desk to rectify.

Event Description

During internal testing, it was found that upon application, the disposable sheaths were cracking and causing shattering in some cases.Not all devices in the batch are affected.Device was not used on a patient.

• Brand Name: OPCLEAR PROCEDURE DISPOSABLE KIT
• Type of Device: endoscopic irrigation/suction system
• Manufacturer (Section D): CIPHER SURGICAL LIMITED; the venture centre; sir william lyons road; coventry, CV4 7 EZ; UK CV4 7EZ
• Manufacturer Contact: krupa srivastava ; the venture centre; sir william lyons road; coventry, CV4 7-EZ ; UK CV4 7EZ
• MDR Report Key: 18994110
• MDR Text Key: 339337525
• Report Number: 3013348547-2024-00001
• Device Sequence Number: 1
• Product Code: OCX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K221824
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CS-10-00-315
• Device Catalogue Number: CS-10-00-315
• Device Lot Number: A48/3/0041/22E
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic