MAUDE Adverse Event Report: COOK INC FLEXI-PET ADJUSTABLE HANDLE SET; MQH ASSISTED REPRODUCTION MICROTOOLS

Catalog Number	K-MPH-1000
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The user facility reported after receiving the flexi-pet adjustable handle set, it was observed to have the same flaws that were found in the previous one that this product was a replacement for.As reported, there is also "oil" in the front part of this product.These issues were discovered prior to patient contact.There was no patient involvement with this issue.
Additional Manufacturer Narrative
Investigation ¿ evaluation: the flexi-pet adjustable handle set was not returned for an evaluation.Photographs were provided for review.Without the complaint device, a physical investigation was not able to be completed.A document based investigation including review of provided photographs, complaint history, the device history record, instructions for use, and specifications was conducted.A review of the device history record found no other non-conformances associated with the complaint device lot number 7481821.A review of complaint history revealed there have been two additional complaints received for this complaint device lot number.One of the additional complaints is associated with this complaint.This associated complaint is for the same failure mode and was received from the same user facility.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Without the actual device, a root cause for the reported issue (some ¿oil¿ in the front part of product) cannot be determined.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: FLEXI-PET ADJUSTABLE HANDLE SET
• Common Device Name: MQH ASSISTED REPRODUCTION MICROTOOLS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6787479
• Report Number: 1820334-2017-02301
• Device Sequence Number: 150243
• Product Code: MQH
• UDI-Device Identifier: 00827002186743
• UDI-Public: (01)00827002186743(17)211201(10)7481821
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K983596
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2018

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
• Operator of Device: No Information
• Device Catalogue Number: K-MPH-1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2017
• Supplement Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 08/11/2017
• Supplement Report FDA Received Date: 03/06/2018
• Patient Sequence Number: 1