MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, MONOPOLAR; ELECTRICAL-ONLY MEDICAL DEVICE CONNECTION CABLE, REUSABLE

Model Number	A0391
Medical Device Problem Codes	Break (1069); Sparking (2595); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On the medwatch report sent by the customer to olympus, the model number (a22255c) and lot number (1000062077) were provided for a surgical electrode.However, an issue with the monopolar cord was described.The monopolar cord a0391 was placed as the model to address the event/issue reported by customer referring to the monopolar cord.Multiple follow ups were made to obtain the information regarding the event reported, however, customer did not provide the information.To date, the device has not yet been returned for evaluation.Supplemental report(s) will be submitted should any relevant new information is available and or received.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
Olympus received a user facility medwatch report with an event description of " shortly after the procedure is started, a loud pop is heard and immediately realized that monopolar cord sparked and broken off where it attaches to esu (electrosurgical unit) machine".Transurethral incision of prostate was the intended procedure.There was no patient harm, no user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The cause of the reported issue is most likely due to age-related wear in connection with improper handling.It can therefore be assumed that the cable was used for longer than the specified 12 months.A definitive root cause cannot be identified.In order to avoid such incidents, the instructions found in the instructions for use (ifu) should be followed.This would be, firstly, that the service life of the cable is limited to 12 months.After this time, the cable should no longer be used.Additionally, the cable must be checked for damage before each use and after reprocessing.By gently pulling on the plug (max.20n), it can be determined whether the copper strand of the cable is already damaged.If the cable does not give way but remains rigid, the cable is most likely intact.In order not to shorten the service life of the cable any further, the cable should not be wound up with a loop diameter of less than 10cm and when pulling out the cable, the plug should be pulled and not the cable.Olympus will continue to monitor the field performance of this device.

• Brand Name: HF-CABLE, MONOPOLAR
• Common Device Name: ELECTRICAL-ONLY MEDICAL DEVICE CONNECTION CABLE, REUSABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 14597438
• Report Number: 9610773-2022-00205
• Device Sequence Number: 17595158
• Product Code: GCJ
• UDI-Device Identifier: 04042761001632
• UDI-Public: 04042761001632
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K944201
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

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: Other
• Device Model Number: A0391
• Device Catalogue Number: A0391
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2022
• Supplement Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ESU (ELECTROSURGICAL UNIT).
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Hispanic