MAUDE Adverse Event Report: RICHARD WOLF GMBH PIRANHA; TUBE FOR SUCTION PVC

Model Number 41702208

Device Problem Collapse (1099)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/06/2021

Event Type  malfunction  

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh.Rw gmbh considers this mdr/complaint open.Rw gmbh will submit a follow up report after the device evaluation has been completed and/or new information becomes available.

Event Description

It was reported to rw gmbh by the user facility that "the tube collapsed during the morcellation procedure.The user replaced the tube, but the error still ocurred.The procedure was completed with a back-up device.The error caused a significant delay in the procedure.".

Event Description

See manufacturer's narrative for results of the device investigation.

Manufacturer Narrative

Follow-up report #1 is to provide fda with missing information, new information, and changed information.The reported tube for suction 41702208 is from the batch 32183371 and it was produced on 05/05/2021.1 pak = 10 pieces was delivered to the user on 06/23/2021.The user has returned 4 pieces of the affected batch for investigation, however not the reported one.No further complaints or events of the affected batch were reported in the period of 01/01/2018 and 12/31/2021.A manufacturing or batch defect is therefor not identifiable.The returned devices were forwarded to the supplier for further investigation.According to the report of the supplier, the returned devices meet the specifications, the reported problem could not be confirmed.Rw gmbh has attempted further investigations: 1) stock verification - practical testing on beef heart tissue scope: retained samples of the affected batch.Retained samples of january deliveries of the last 5 years.Current stock product.Result: on some tubes, a deformation could be reproduced during testing, however a malfunction of the suction could not be proven or confirmed.2) clinic visit the reported problem of "collapsing tubing" was replicated during a procedure, but no malfunction of the tube was observed.3) material analysis in order to identify any variation in the material properties of the tubes, selected tube samples (products from complaints, retained samples and current stock goods) were analyzed in a independent laboratory.The test results show no noticeable differences between the tube samples, and no function-impairing variations in the material properties could be identified.No product problem could be identified with the respect to tube for suction 41702208.However, the affected product was used in combination with othet medical devices, but the products used in combination were not returned for investigation.The cause could not be determined.Since defective suction can have various causes, including in the use of the product, the relevant notes and warnings from the ifu ga-a 252-usa / en / 2012-07 v2.0 / pdg 11-5360 are listed: 3 set up 3.1.3 connection diagram [fig.3 with legend] 3.1.4 description of connections general notes and instructions: establish the tube connections in accordance with the guided menu of the piranha suction pump or the overview in section 3.1.3.The following is a detailed description of the individual steps.For the reprocessing of the accessories see section 6.Connection and tube connections: connect the suction pump piranha 2208 and the power control 2303 with the connecting cable (section 3.1.2).Connect the footswitch to the suction pump.Connect the overflow protection/bacteria filter (c) to the elbow connector of the vacuum tube (a) and then the overflow protection/bacteria filter (c) to the lid of the "vacuum" secretion container.Make sure that the float valve (16.2) is installed in the lid (16.1).Connect the vacuum tube (a) to the vacuum connector of the device.Connect the vacuum tube (b) to the motorized handle (18).Clip the cable from the motorized handle into the cable holder on the suction tube (b1).Connect the suction tube (b) to the lid of the secretion container "patient".Optionally a tissue trap can be connected between the lid and the suction tube (is urgently recommended) (d) to collect any severed tissue parts (observe the mounting position (x) of the overflow protection/bacteria filter, turn the overflow protection/bacteria filter 180 degrees if necessary).Place the suction tube (b) into the clamping valve (see section 5.2.4).4 checks important! run through the checks before and after each use.Do not use the products if they are damaged or incomplete or have loose parts.Return damaged products together with any loose parts for repair.Do not attempt to do any repairs yourself.4.1 visual checks check the device and accessories for damaged, loose or missing parts, hygiene and completeness.Check all connection cables and tubes/hoses for damage.Check instruments and accessories for damage, sharp edges, loose or missing parts and rough surfaces.Check all connection tubes/hoses for damage, hygiene and completeness.Check o--rings and sealing caps as well as insulating parts for perfect condition.Any inscriptions, lettering or identification necessary for the safe intended use must be legible.Any missing or illegible lettering, labeling or identification leading to wrong handling or reprocessing must be reinstated.Vacuum tube (a) must be dry inside (see reprocessing).Check overflow protection/bacteria filter (c) for soiling.Disposable vacuum tube (b), sterile.If the sterile packaging is damaged or the use--by date exceeded, use a new disposable suction tube.There must be an o--ring (18.1) in the tool holder (clamping head) of power stick m4.The o--ring must be undamaged.If the o--ring (18.1) is damaged, cut open the o--ring with a scalpel and replace.Important! the o--ring seals the tool towards the handle.If the o--ring is damaged, the full vacuum cannot be established.[fig.5] 4.2 function check important! in order to carry out the function checks, the devices must be in flawless condition and set up correctly.Carry out a visual check in order to guarantee this condition.Piranha suction pump: the piranha suction pump is equipped with automatic function checks which automatically detect and report their various errors or faults.The errors or faults detected may occur during the self--test or during operation.Switch on the power switch.After each switch--of the power switch the device runs through an automatic function test (approx.10 seconds).Any fault or error detected is displayed on the lcd display (see section 5.7).On successful completion of the test, the piranha suction pump is operational.Connect the complete system in accordance with section 3.5 use 5.2.4 inserting/removing the suction tube to insert/remove the suction tube, open the clamping valve as follows: in operation level: -- in the auxiliary menu (place suction tube into clamping valve) the clamping valve opens.In the configuration level (menu): -- install/remove tube the clamping valve opens.To insert/remove the suction tube proceed as follows: slightly pull the suction tube and place it completely (horizontally) into the clamping valve (fig.7).Make sure you don't hold the suction tube by the connectors.[fig.7] 5.7.2 messages in operating mode error message: vacuum build-up defective, please check container and tube set for leaks possible cause: defective or leaking tubing / secretion container silencer clogged corrective action: check tubing / secretion container replace silencer 7 technical description 7.1 troubleshooting error message: tissue parts are aspirated with difficulty or not at all possible cause: hoses/tubes incorrectly connected, kinked or defective missing vacuum suction channel in the instrument clogged overflow protection / bacteria filter clogged corrective action: check the tube connections / fittings for leak tightness and correct connection; replace, if necessary.Check for proper tube connection check instrument channel for free passage; replace, if necessary replace overflow protection / bacteria filter error message: no or insufficient suction flow possible cause: tubes improperly connected or defective lid of secretion container leaking silencer clogged tubes kinked or clogged suction channel of instrument clogged overflow corrective action: check tube connections for leakage and correct connection; replace, if necessary.Check lid of secretion container for leak tightness and replace, if necessary.Replace silencer check the tubes, clean or replace, if necessary clean suction channel, replace if necessary change overflow protection / bacteria filter according to the risk assessment e3-2 r00 for the product type 41702208, the reported defect is considered and classified as acceptable.The medical benefit-risk ratio is still within an acceptable range.The measures described are to be considered sufficient.Rw gmbh considers this matter closed.However, in the event rw gmbh receives any additional information, a follow-up report will be submitted to fda.Rwmic is submitting the report on behalf of rw gmbh.

• Brand Name: PIRANHA
• Type of Device: TUBE FOR SUCTION PVC
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 12217083
• MDR Text Key: 265600496
• Report Number: 9611102-2021-00027
• Device Sequence Number: 1
• Product Code: OCX
• UDI-Device Identifier: 04055207054376
• UDI-Public: 04055207054376
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K041610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 41702208
• Device Catalogue Number: 41702208
• Device Lot Number: 32183371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2021
• 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 Age: 64 YR
• Patient Sex: Male