MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, BIPOLAR, 4 M, TURIS/TCRIS RESECTOSC

Model Number WA00014A

Device Problems Break (1069); Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2017

Event Type  malfunction  

Manufacturer Narrative

The referenced device was not returned to olympus for evaluation.The cause of the reported event could not be conclusively determined.However, the instruction manual contains warning statements in an effort to prevent damage to the cable, to ¿visually inspect the entire hf-cable.Do not use a hf-cable with a brittle or defective insulation.Replace the hf cable if necessary.¿ also, ¿reprocessing and mechanical stress damages the hf-cable.After the first use, the hf cable has a service life of 12 months.Dispose of the hf cable after 12 months.¿.

Event Description

The user facility reported that during the middle of a therapeutic transurethral resection of the prostate (turp) procedure, there was a spark and a loud popping sound.The device broke in half where the cable is fused to the right angle plug.The physician¿s glove was blackened , however, no patient or user injury was reported.The esu settings were 100/120.No error message on the esu was observed prior to the incident and no evacuation was needed.The intended procedure was completed using a similar device.

Manufacturer Narrative

The oem performed a quality control review for the reported lot number and no abnormalities noted.Additionally the oem performed a device history review (dhr) and no non-conformities noted during the manufacturing of the device.

• Brand Name: HF-CABLE, BIPOLAR, 4 M, TURIS/TCRIS RESECTOSC
• Type of Device: HF-CABLE, BIPOLAR
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6324365
• MDR Text Key: 67223104
• Report Number: 2951238-2017-00079
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2017

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 Number: WA00014A
• Device Catalogue Number: WA00014A
• Device Lot Number: 166W-3882
• Other Device ID Number: 04042761076449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/17/2017
• Initial Date FDA Received: 02/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1