MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. COLONOVIDEOSCOPE

Model Number CF-H170L

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Perforation (2001)

Event Date 08/31/2022

Event Type  Injury  

Event Description

The customer reported two different patients had an intestinal perforation when using a two different endoscopes with stiff insertion tubes.For patient 1 of 2, during a diagnostic colonoscopy, the insertion tube was stiff and caused an intestinal perforation.The perforation was treated with an endo clip and antibiotics.Patient was admitted to the icu in stable condition.The patient was discharged in normal condition.For patient 2 of 2, during a diagnostic colonoscopy, the insertion tube was stiff and caused an intestinal perforation.The perforation was treated with an endo clip and was discharged without further issues.The surgeon reported the a large insertion diameter and stiff device is not recommended to be used by a novice physician.(b)(6): patient 1 cf-h170l, serial (b)(4).(b)(6): patient 2 cf-h170l, serial (b)(4).This report is 2 of 2 for (b)(6): patient 2 cf-h170l, serial (b)(4).

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.The olympus service team evaluated the device and identified the following: the reported stiff insertion tube was not confirmed, the bending section cover adhesive was detached, and play of the right/left knob does not met specifications and wear of angle wire.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, as the stiff insertion section was not confirmed, the root cause of the reported event could not be determined.The user may be able to reduce/prevent occurrence of the suggested event by handling the device in according with the following from the device's instructions for use: ¿if it is difficult to insert the endoscope, do not forcibly insert the endoscope; stop the endoscopy.Forcible insertion can result in patient injury, bleeding, and/or perforation.·never perform flexibility adjustment, operate the bending section, feed air or perform suction, insert or withdraw the endoscope¿s insertion section, or use endotherapy accessories without viewing the endoscopic image or while the endoscopic image is frozen.Patient injury, bleeding, and/or perforation may result.·regardless of the flexibility of the endoscope¿s insertion tube, never insert or withdraw the insertion section abruptly or with excessive force.Patient injury, bleeding, and/or perforation may result.Do not attempt to bend or twist the endoscope¿s insertion section with excessive force regardless of its flexibility.The insertion section may be damaged.¿ per the legal manufacturer, the other device defects included in the initial mdr (the bending section cover adhesive was detached, play of the right/left knob did not meet specification, and wear of the angle wire) have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.Olympus will continue to monitor field performance for this device.

• Brand Name: COLONOVIDEOSCOPE
• Type of Device: COLONOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15606087
• MDR Text Key: 301733160
• Report Number: 9610595-2022-02946
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170334160
• UDI-Public: 04953170334160
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K112680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF-H170L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2022
• Date Device Manufactured: 10/15/2015
• 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
• Patient Outcome(s): Required Intervention; Other