MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH; RESECTOSCOPE

Model Number A22040A

Device Problem Material Separation (1562)

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

Event Date 03/10/2022

Event Type  malfunction  

Event Description

The customer reports during an unspecified surgical procedure using a 26fr.Inner sheath, the ceramic distal tip cracked and a shard fell off into the patient.The user was able to retrieve everything out of the patient.There were no additional consequences to the patient reported.Additional details were requested regarding the patient and reported event with no response from the customer.

Manufacturer Narrative

This report is being submitted to report information provided by the customer and investigation findings.Physical evaluation of the suspect device: olympus performed a visual inspection on the received condition and discovered a portion of the ceramic insulation at the sheath's distal end broken off, which was not returned for evaluation.Olympus estimates that approximately 30 percent of the ceramic insulation is missing; the remaining insulation is still intact to the inside of the sheath.The edges left by the missing piece of ceramic insulation are very sharp.The sheath has minor scratches in various locations throughout.Additionally, the release knob functions as intended.Device history record (dhr) review a manufacturing and quality control review was performed for device a22040a with lot number 21313.There is no non-conformity associated with this device with respect to the described issue.The dhr review showed that the device was manufactured according to valid instructions and met all specifications.The instructions for use (ifu) shipped with the device provides the user with the following instructions related to the reported event: prior to using medical devices, please ensure they are in perfect technical condition.See also the warnings in the instructions for use (ifu).4 before use warning infection control risk: properly reprocess the product before first and each subsequent use following the instructions in this manual and in the system guide endoscopy.Improper and/or incomplete reprocessing can cause infection of the patient and/or medical personnel.4.1 inspection and testing inspecting the product: visually inspect the product.Make sure that it has: -- no corrosion -- no dents -- no scratches ceramic insulation at distal end: visually inspect the ceramic insulation at the sheath¿s distal end before each use.Do not use the instrument in case of damage (e.G cracks, fractures).Warning risk of injury: impact, fall, shock or similar stress can damage the ceramic insulation at the sheath¿s distal end.Damaged instruments can cause injuries to the patient and/or user.Do not use the instrument if damaged.Damaged product: if the product is damaged or does not function properly, contact an olympus representative or an authorized service center.The ifu also carries a warning that the ceramic tip can break due to mechanical loading or thermally induced straining.Thus, it is the responsibility of the user to inspect the instrument prior to every procedure.The definitive cause of the user's experience could not be determined.Based on the investigation findings, the following are likely to be contributing factors: analysis according to the event description, the broken fragment of the ceramic insulating insert was located and removed.It should be mentioned that no patient damage was reported.Also, no other damage to the shaft was reported.Based on the described damage pattern, it can be assumed the insulation tip's damage was caused by mechanical thermal influence.Unfortunately, it cannot be determined with certainty, whether there was a previous damage on the device or any damage on the ceramic insulating insert was caused during last reprocessing or during last usage.The ifu carries a warning that the ceramic tip can break due to mechanical loading or thermally induced straining.Thus, it is the responsibility of the user to inspect the instrument prior to every procedure.As for the technical cause, it is assumed that the damage of the insulation material of the sheath was caused by thermal mechanical overload, improper handling, mechanical impact like fall, shock or similar stress.Also note that the cause of the reported issue is attributed to wear and tear.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: RESECTOSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 14046125
• MDR Text Key: 298506890
• Report Number: 9610773-2022-00129
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761029339
• UDI-Public: 04042761029339
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/07/2022

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: A22040A
• Device Catalogue Number: A22040A
• Device Lot Number: 21313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2022
• Initial Date FDA Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• 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