MAUDE Adverse Event Report: CIPHER SURGICAL LTD OPCLEAR DISPOSABLE PROCEDURE KIT; LAPAROSCOPE LENS CLEANER

Catalog Number CS-SZ10-00 CONTINUED

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/09/2022

Event Type  malfunction  

Manufacturer Narrative

There has only been a small number of affected devices used for sales evaluation with patients in the us.This product has been under the control of cipher sales staff.No product has been distributed to hospital inventory; there is no affected product in hospitals.Therefore there are no product to retrieve, hence no remedial action has been initiated.Four product variants of opclear disposable procedure kit and batches are affected: cs-sz10-00 lot a25/2/0041/21z, cs-sz10-30 lot a26/2/0041/21y, cs-sr10-00 lot a28/2/0041/21w, cs-sr10-30 lot a27/2/0041/21x.

Event Description

During internal testing by the manufacturer it was found that small (circa 0.5mm) sterile plastic fragments of the device were present on some devices due to a manufacturing defect.Not all devices in the batch are affected.Four product codes and batches are affected: cs-sz10-00 lot a25/2/0041/21z, cs-sz10-30 lot a26/2/0041/21y, cs-sr10-00 lot a28/2/0041/21w, cs-sr10-30 lot a27/2/0041/21x.There is a very small possibility that these fragments could enter the patient abdominal cavity during product use.The probability of patient harm occurring is assessed to be very low based on the likelihood of the fragment entering the patient and then there being an adverse foreign body reaction.There have been no reports of adverse incidents from this defect in any market that the product is available.

• Brand Name: OPCLEAR DISPOSABLE PROCEDURE KIT
• Type of Device: LAPAROSCOPE LENS CLEANER
• Manufacturer (Section D): CIPHER SURGICAL LTD; the venture centre; sir william lyons road; coventry, west midlands CV47E Z; UK CV47EZ
• Manufacturer (Section G): CIPHER SURGICAL LTD; the venture centre; sir william lyons road; coventry, west midlands CV47E Z; UK CV47EZ
• Manufacturer Contact: tom littleford ; the venture centre; sir william lyons road; coventry, west midlands CV47E-Z ; UK CV47EZ
• MDR Report Key: 13757509
• MDR Text Key: 297147083
• Report Number: 3013348547-2022-00001
• Device Sequence Number: 1
• Product Code: OCX
• Combination Product (y/n): N
• PMA/PMN Number: K171637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS-SZ10-00 CONTINUED
• Device Lot Number: A25/2/0041/21Z CONTINUED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2022
• 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