MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR.,

Model Number A22201C

Device Problem Arcing of Electrodes (2289)

Patient Problem Burn, Thermal (2530)

Event Date 09/29/2016

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to olympus for evaluation.The cause of the reported event could not be determined.The instruction manual states, ¿improper use of hf current can cause endogenous or exogenous burns, and explosions.Thoroughly review the hf current safety information included in the olympus endoscopy system guide.If any damage to the insulation at the electrode¿s distal end becomes visible during use, replace the electrode with an undamaged electrode.Otherwise there is a risk of injury for the patient and/or user.¿.

Event Description

Olympus was informed that during an unspecified therapeutic procedure, the electrode loop arced and burned the patient's uterus.The insulation at the tip of the loop was also burnt.The procedure was completed using a different electrode loop.It is unknown if the patient required an intervention.

Manufacturer Narrative

Olympus received additional information on october 7, 2016 stating that the reported patient burn occurred during a hysteroscopy and polypectomy procedure when the physician was attempting to remove a polyp from the patient's uterus.It was also reported that the patient's burn was not severe.No medical or surgical intervention was required.The patient is reportedly doing fine.The device was inspected prior to use.

Manufacturer Narrative

The reported device was returned to olympus for evaluation; however, the user facility¿s hysterescope/resectoscope that was used in conjunction with the reported device was not returned to olympus.The evaluation confirmed the reported device damage.A visual inspection of the device noted deformation on both of the resector post.A microscope was used and found charred stains on the metallic post.To add, one of the yellow posts was completely missing.Scrape marks were also noted on the metallic post where the charred stains were located.The scrape marks can occur when the device comes in contact with a hard like/metal objects.Based on the investigation findings, the cause of the reported event is likely attributed to the operator's technique and the device coming in contact with a hard like/metallic object when the high frequency (hf) output was activated, which can cause premature melting of the loop.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR.,
• Type of Device: HF-RESECTION ELECTRODE, LOOP, 24 FR.
• 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: 6006532
• MDR Text Key: 56757116
• Report Number: 2951238-2016-00791
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK903323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22201C
• Device Catalogue Number: A22201C
• Device Lot Number: 16006P03L001
• Other Device ID Number: 14042761036648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other