MAUDE Adverse Event Report: DEPUY MITEK LLC US REUSE PATIENT SET FMS 24PK; SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE

Model Number	284649
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Investigation summary: according to the information provided, it was reported that the reuse patient set fms 24pk.Upon setting up the fms, the water doesn't flow up to the scope.Noticed increased pressure on the bag and water doesn't flow.The complaint device is not being returned, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, observations reveals only the one-way valve from the 284649-tube set reported.It was found in the photo that there not presented rest of fluid in the section of the tube near the filter.The pressure test would help to find leaks in the tube set.Hands on analysis should provide more evidence to be able to discern a root cause.The photo don¿t provide evidence of the failure reported into device, therefore the complaint reported cannot be confirmed.The possible root cause can be attributed to an excessive force by the surgeon, whether the insertion was off axis during the procedure.As a result, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number:4917, and no non-conformances related to the reported complaint condition were identified. at this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi:(b)(4).
Event or Problem Description
It was reported by affiliate via complaint submission tool the reuse patient set fms 24pk.Upon setting up the fms, the water doesn't flow up to the scope.Noticed increased pressure on the bag and water doesn't flow.The device is available to be returned for evaluation.Additional information provided by the affiliate reported surgical delay or patient impact did not occur due to the reported event.It was also reported the case was successfully completed by using the same device but by pricking the pouch of the product with a needle in order to increase water flow.

• Brand Name: REUSE PATIENT SET FMS 24PK
• Common Device Name: SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10605174
• Report Number: 1221934-2020-02809
• Device Sequence Number: 2940766
• Product Code: HRX
• UDI-Device Identifier: 10886705023233
• UDI-Public: 10886705023233
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K951843
• 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
• Report Date (Section B): 09/27/2020

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: Health Professional
• Device Expiration Date: 06/29/2020
• Device Model Number: 284649
• Device Catalogue Number: 284649
• Device Lot Number: 4917
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2020
• Initial Report FDA Received Date: 09/30/2020
• Patient Sequence Number: 1
• Patient Age: 52 YR