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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12-30, ESG TURIS

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OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12-30, ESG TURIS Back to Search Results
Model Number WA22706S
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/27/2020
Event Type  malfunction  
Manufacturer Narrative
The device referenced in this report has not been returned to olympus for physical evaluation.The definitive cause of the customer's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
 
Event Description
It is reported during a cystoscopy and transurethral resection of the prostate (turp) using a hf-resection electrode (plasma loop) with a borrowed resectoscope, the first loop broke during the case and fell into the patient.They removed the first broken electrode.(this report).A second loop was opened and upon starting to use the second electrode, it broke as well and fell into the patient.The doctor was not able to remove this loop fragment (reported in related complaint with patient identifier (b)(6)).A third loop was opened, it partially broke, but did not fall into the patient (reported in related complaint with patient identifier (b)(6)).The user then pulled out their own resectoscope working element and opened a 4th loop.The procedure was then completed without any further difficulty.There was no other changes to the fluid, generator, or settings.The user could not verify if the borrowed working element was the exact same model cause as their resectoscope.The patient did not experience any adverse effects as a result of this occurrence and was discharged as planned.
 
Manufacturer Narrative
This report is being updated to provide investigation findings.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.Conclusion: based on the data presently available, it is concluded that excessive force in combination with anatomical or procedural complication during surgery contributed to the reported event.
 
Manufacturer Narrative
This report is being updated to provide additional investigation findings.Investigation analysis update: the patient received standard, continuous, high-flow bladder irrigation for up to 24 hours after the turp procedure.This bladder irrigation probably flushed any remaining fragment of the loop out of the bladder.There is no known problem related to the event after the patient's discharge.Moreover, even if a fragment remained in the bladder, it is unlikely to cause a serious injury afterwards.The returned first electrode that broke during the procedure and was retrieved shows a wire breakage where the loop has melted down to the fork insulation.This procedure can sometimes be very dynamic, especially if the plasma arc is maintained and the surgeon notices the damage to the loop belatedly.There are melting points on the ceramic insulation tubes as well as clear traces of heat development on the insulation tubes.The minor rust at the proximal end of the electrode was most likely caused by dried rinsing solution and is not related to the distal damage on the loop.
 
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Brand Name
HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12-30, ESG TURIS
Type of Device
HF-RESECTION ELECTRODE "PLASMALOOP"
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, hamburg 22045
GM  22045
MDR Report Key11064888
MDR Text Key227215108
Report Number9610773-2020-00301
Device Sequence Number1
Product Code FAS
UDI-Device Identifier14042761085356
UDI-Public14042761085356
Combination Product (y/n)N
PMA/PMN Number
K171965
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup,Followup
Report Date 08/30/2021
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
Device Operator Health Professional
Device Model NumberWA22706S
Device Catalogue NumberWA22706S
Device Lot Number1000061354
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/27/2020
Initial Date FDA Received12/23/2020
Supplement Dates Manufacturer Received03/11/2021
08/12/2021
Supplement Dates FDA Received03/30/2021
08/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age65 YR
Patient Weight84
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