MAUDE Adverse Event Report: FLEXIBLE SCOPE LARGE DIAMETER VIDEO PEDIATRIC COLONOSCOPE OLYMPUS

Model Number FS.10578

Device Problem Device Handling Problem (3265)

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

Event Date 10/06/2022

Event Type  malfunction  

Manufacturer Narrative

During the procedure, the bending section of the flexible colonoscope detached and the bending rubber tore.Under previous repair, srn (b)(4), the device was repaired and passed outgoing quality control inspection without damages or functional issues before returning to the customer.Flexible scope large diameter video pediatric colonoscope olympus pcf-h190dl was returned to ims (b)(4) lab on october 11th, 2022 for evaluation.Upon investigation, it was found that the joint where the passive bending section attaches to the coil pipe housing had separated.The mating parts appeared to be in good condition and there was evidence that the appropriate installation steps were followed during the previous servicing.There was enough adhesive in the appropriate area and the screws were still in place.It appeared that a strong force may have been applied in a twisting motion as both side tabs were flared out.This type of damage is typically caused by twisting of the bending section which can cause the adhesive to break free causing the screws to ride under the tabs.The device usage counter indicated that it had been used over 200 times since the previous repair.The lab was unable to determine if the damage to the bending section occurred during use in the procedure or before as it is possible that the bending section may have broken free during cleaning and/or handling prior to the procedure.At that point, the bending rubber may have been holding the bending section together until it finally tore.Due to the nature of the damage and the amount of usage since the previous repair, it is unlikely that the detachment of the bending section was related to the previous device servicing and was likely attributed to improper care and handling at the user facility.To address the issues identified, repair services ang901 - angulation adjusted w/stoppers (190 series), bnr900 - bending rubber replaced (190 series), int062 - colonoscope insertion tube replaced, bns904 - bending section replaced (190 series), and fer903 - olympus 190 series - flexible endoscope refurbished - level two were performed on the device and passed outgoing quality control inspection on 10/18/2022.

Event Description

The user facility reported that the bending section of flexible scope large diameter video pediatric colonoscope olympus pcf-h190dl 'fell apart' during procedure.No injury was attributed to this event however the reported issue led to a minor procedural delay of five minutes or less as another device had to be pulled to complete the procedure.

Manufacturer Narrative

On 11/07/2022, the user facility personnel were advised of the lab's findings and were counseled regarding the proper care and handling of the flexible scope large diameter video pediactric colonoscope lypus pcf-h190dl by a steris account manager.No additional issues have been reported.

• Brand Name: FLEXIBLE SCOPE LARGE DIAMETER VIDEO PEDIATRIC COLONOSCOPE OLYMPUS
• Type of Device: COLONOSCOPE
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 15737575
• MDR Text Key: 307672096
• Report Number: 1527821-2022-00006
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FS.10578
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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