MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMABAND", BAND, MEDIUM, 24 FR., 12°-30°, PK TURIS; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE

Model Number WA22623S

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2024

Event Type  Injury  

Event Description

It was reported that towards the end of the transurethral resection of the prostate procedure, the physician noted the cut/cautery tip/loop, which was a very small piece, of the hf-resection electrode loop had broken off.It was reportedly a really big prostate and thus, a really long case.Attempts to search the broken piece were made but with no success.As such, an x-ray was undertaken that found no pieces of the device inside the patient's body.The procedure was completed without delay using a similar device.It was confirmed that the device was inspected prior to use.There were no reports of patient harm.

• Brand Name: HF-RESECTION ELECTRODE "PLASMABAND", BAND, MEDIUM, 24 FR., 12°-30°, PK TURIS
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 18685572
• MDR Text Key: 335129652
• Report Number: 2429304-2024-00106
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/30/2024,02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22623S
• Device Lot Number: 1000113415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/30/2024
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 01/30/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White