MAUDE Adverse Event Report: COOPERSURGICAL, INC. CPO-6

Model Number CPO-6

Device Problem Nonstandard Device (1420)

Patient Problem Unspecified Infection (1930)

Event Date 10/03/2018

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.The actual device involved in the complaint cannot be returned because it was discarded by the user.Once the investigation is completed and a follow-up report will be filed.Reference (b)(4).

Event Description

On 19th october 2018, ken medical received 3 cases of the patient infection after the surgery using the cpo-6 from one hospital.Hospital name: (b)(6) hospital.Lot numbers and the surgery dates: 247608 - (b)(6).248879 - (b)(6) / (b)(6) october ( 1 each).The surgeon is the experienced doctor both on the surgery and the product.The reason of the infection is suspected both from the product or in-hospital reasons.In order to clarify the root cause, hospital is requesting to certify that the product was properly sterilized.The used products are discarded.The other items of these lots are brought back to ken medical.The used products ( on recall ) were well inspected and the pouch problem was not observed.

Manufacturer Narrative

Investigation: x-initiated manufacturer's investigation: x-no sample returned.X-review dhr.*analysis and findings: similar to complaint (b)(4).*was the complaint confirmed? no.Reviewed dhr for lot wo# 248879 and there were no issues identified either during processing in facility nor at sterilization performed at steris under po lot # 145298 in jul 2018.The certificate of processing at steris for the sterilization lot #145298.There were no non-conformances.However, since this lot was produced using pacmed sealer and 100% inspection for seals performed with tool after sterilization, in response to capa 719 and 196 units were released for shipment after completion.Per communications within it is clear that the product at ken medical was tested and the test results came up negative for sterility tests.Below are the statements quoted from this communication "based on the request from the hospital, ken medical performed the sterility test on the products of the lot numbers of 247608 and 248879.Today the result was reported to be negative.In the meantime, the other incident ( infection ) was found at the same hospital with the different lot number.From that, ken medical suspects that the root cause of this incident is not derived from products." the two year complaint history shows no issues related to seal compromise or open packages.This report is being submitted as part of a retrospective review of our reportable events, please be aware it occurred in 2018.

Event Description

On 19th october 2018, ken medical received 3 cases of the patient infection after the surgery using the cpo-6 from one hospital.Hospital name: (b)(6) hospital.Lot numbers and the surgery dates: 247608 - (b)(6).248879 - (b)(6) ( 1 each).The surgeon is the experienced doctor both on the surgery and the product.The reason of the infection is suspected both from the product or in-hospital reasons.In order to clarify the root cause, hospital is requesting to certify that the product was properly sterilized.The used products are discarded.The other items of these lots are brought back to ken medical.The used products ( on recall ) were well inspected and the pouch problem was not observed.

• Brand Name: CPO-6
• Type of Device: CPO-6
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC,; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate dr.; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 8004749
• MDR Text Key: 124986003
• Report Number: 1216677-2018-00065
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K954311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2021
• Device Model Number: CPO-6
• Device Catalogue Number: CPO-6
• Device Lot Number: 248879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention