MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 30°, STERILE, SINGLE USE; HF-RESECTION ELECTRODES

Catalog Number WA22306D

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tissue Damage (2104); Stenosis (2263); Burn, Thermal (2530)

Event Date 04/01/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products and therapy dates device evaluation: the suspect medical device was not returned to the manufacturer for evaluation/investigation.However, several concomitant medical products were returned and evaluated/investigated.The result of the investigation is only partly consistent with the description of failure.Based solely on the provided description of the event/incident, several indicators of incorrect handling could be found.According to the provided information, single-use hf resection electrodes were reprocessed and reused several times.Also, the operating surgeon apparently used an incompatible external sheath.Apparently, the outer sheath a22021a was used which is not compatible with the inner sheath a22040a.However, the outer sheath a22026a was sent to olympus.This outer sheath a22026a is indeed compatible with the inner sheath a22040a.Additionally, it was stated that the hf cable wa00013a with the lot number 08zw was used during the procedure.The lot number indicates that the item was manufactured in december 2008.As clearly stated in the instructions, the hf cable is subject to a restricted service life of one year and must not be used upon expiry of this time period.As a consequence, the cable was most likely not used in accordance with the instructions.The above stated information clearly indicate contradictions to the intended use and, consequently, incorrect handling by the user.The ues-40 electrosurgical generator and the foot switch maj-1258 were tested together with the accessories and another hf resection electrode and hf cable.The hf resection electrode could be activated and the saline detection also functioned without any problems.However, there are burn marks on the generator's socket for the hf cable.These marks indicate that a spark had occurred.The obturators, working element, and sheaths were thoroughly investigated.All of these items have lot numbers indicating that they were manufactured in 2008 or 2009.Consequently, it can be assumed that these items were in use for several years.All have signs of wear and tear and are no longer in accordance with the specification.The laser labeling is fading and traces of rust can be found on some of the screws.Furthermore, the distal tip of the outer sheath a22026a is deformed and has some burs.Still, the inner sheath a22040a can be inserted and mounted without any problems.The inner sheath a22040a is bent and the position of the electrode's loop is no longer aligned properly to the edge of the ceramic insulation on the sheath's distal tip.Except for signs of wear and tear, the ceramic insulation is still intact.The working element wa22366a is bent and the telescope cannot be inserted.The hf resection electrode can be inserted without problems and the electrode contact is in a good condition.The thumb ring and the ptfe/main body are severely worn.Also, the ptfe/main body has been opened by an unauthorized third party.The electric safety has been tested and is still given.However, due to the mentioned damage, the working element is not in standard.Based on these investigation results, the event/incident was attributed to abnormal use/off-label use in combination with exceeded service life/shelf-life.The case will be closed from olympus side with no further actions.However, the event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results and pro re nata trained again on the correct usage of the olympus medical devices.

Event Description

Cross-reference to mfr report # 9610773-2015-00023 and 9610773-2015-00024.This is report 3 out of 3.Olympus was informed that after three individual transurethral resection of the prostate in saline (turis-p) procedures in (b)(6) 2014 (2) and (b)(6) 2015 (1), the patients reportedly suffered from severe burns in the area of the external urethral orifice (urinary meatus).Furthermore, both of the patients who were treated in (b)(6) 2014 subsequently developed multiple urethral strictures and a significant shrinkage of the bladder.However, none of the olympus medical devices used during the procedures showed any malfunction.Furthermore, it was reported that the overall system was inspected at the user facility by a technician of the distributor after the procedures in (b)(6) 2014.During this inspection, no malfunction of the olympus medical devices was found, but it was observed that the single-use hf resection electrodes had been reprocessed and reused on a patient, and that the resectoscope was used in combination with an incompatible external sheath.No further information was provided.

Manufacturer Narrative

The suspect medical devices were not yet returned to the manufacturer for evaluation/investigation.Therefore the exact cause of the patients' outcome and the user's experience could not be determined and is being judged as unknown.However, if the suspect medical devices are returned for evaluation/investigation or additional significant information becomes available, this report will be updated.Olympus submits this incident as a medical device report (mdr) in abundance of caution.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 30°, STERILE, SINGLE USE
• Type of Device: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, 2204 5; GM 22045
• Manufacturer (Section G): OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O.; telickova 457/29; prerov, 7512 4; EZ 75124
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg, 22045 ; GM 22045 ; 4066966
• MDR Report Key: 4826212
• MDR Text Key: 13972093
• Report Number: 9610773-2015-00025
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K100275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: WA22306D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: INSERT TRAY, FOR UROLOGY (A5976); OBTURATOR, OPTICAL, 24 FR. (A22071A); HF-CABLE, 4 M (WA00013A); UES-40 ELECTROSURGICAL GENERATOR (S/N:(B)(4)); OBTURATOR, 24 FR. (A22081A); OUTER SHEATH, 26 FR., 2 STOPCOCKS (A22026A); MAJ-1258 FOOT SWITCH FOR UES-40; WORKING ELEMENT, ACTIVE, FOR TURIS (WA22366A); INNER SHEATH, FOR 26 FR. OUTER SHEATH (A22040A); INSTRUMENT TRAY, LARGE, WITH LID (WA05970A); OUTER SHEATH, 26 FR., 2 STOPCOCKS (A22021A)
• Patient Outcome(s): Required Intervention