MAUDE Adverse Event Report: RICHARD WOLF GMBH; SUCT./IRRIG.TUBE SET SPIKE L 3M

Model Number	4170956
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Richard wolf gmbh has not received the reported device for investigation.
Event or Problem Description
A user facility representative reports an issue regarding suct./irrig.Tube set spike l 3m pvc part no.4170956 with lot no.32224432.The representative reported that the tube for suction collapses and cannot be fixed.It cannot suction large amounts or thicker amounts of fluid.They would have to open the patient up in order to suction properly.
Additional Manufacturer Narrative
New information: b4, d9, g1 (contact), g3, g6, h2, h6 (type of investigation, investigation findings, investigation conclusions), and h10.Richard wolf gmbh has not received the reported device for investigation.The root cause cannot be determined.The suct./irrig.Tube set spike l 3m 4170956 is used in conjunction with suction and irrigation handle 8385.901 and suitable irrigation containers, pumps as well as fluid traps or secretion containers.A probable root cause could be a too high selected pressure at the pump pressure which damages the suct./irrig.Tube set spike l 3m 4170956.If the pressure is selected too high, it causes leakage within the suction-purge system or pinch valves.The suct./irrig.Tube set spike l 3m 4170956, batch 32224432 was manufactured on 02/jun/2022.The batch consisted of 573 pak of suct./irrig.Tube set spike l 3m.One pak consists 10 pieces of the device.No issue was identified during production.In the review period between 01/jan/2020 and 06/feb/2023, 4 similar complaints were reported.In 2 complaints, the reported issue could not be confirmed.In 2 complaints, the root cause was identified as user error due to too high selected pressure at the pump pressure which damaged the suct./irrig.Tube set spike l 3m 4170956.The ifu ga-b145 / en / 2021-03 v8.0 / pk20-0269 / for the system contains several safety instructions and notes about the limited strength of the device as well about the maximal allowed level of pressure within the suction-purge system in section 7 use and in section 7.2 general notes and instructions for use.Also, there is safety notes regarding the device combination in section 5 combinations.Furthermore, the user is advised about a visual and functional checks of the entire system prior a procedure in section 8 checks.The subject issue of incorrect device combination is present in the risk management file f1-2: suction and rinsing tubes, rev.03.The overall probability of occurrence for this issue remains at previously defined levels and overall risk of the device remains in the acceptable category.

• Brand Name: NA
• Common Device Name: SUCT./IRRIG.TUBE SET SPIKE L 3M
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 16471103
• Report Number: 9611102-2023-00014
• Device Sequence Number: 20767897
• Product Code: GEI
• UDI-Device Identifier: 04055207048641
• UDI-Public: 04055207048641
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K002000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/01/2025
• Device Model Number: 4170956
• Device Catalogue Number: 4170.956
• Device Lot Number: 32224432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown