MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH, WITH A22085A

Model Number A22040T

Device Problems Break (1069); Fracture (1260)

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

Event Date 01/04/2022

Event Type  malfunction  

Event Description

Olympus (oms) was informed by the doctor at the user facility that ¿almost finishing a resection, the doctor noticed that there was a black fragment in the bladder, the doctor stopped and confirmed that the bevel of the inner sleeve had fractured inside the patient, the doctor removed it and finished the procedure.There was no patient damage or port -surgical problems derived from the event.¿.

Manufacturer Narrative

The legal manufacturer performed a review of the device history records for the concerned device and no abnormalities were found.The product was sold on october 29, 2020.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.Based on the described damage pattern, the potential cause of the damage of the insulation material of the sheath was caused by thermal mechanical overload, improper handling, mechanical impact like fall and or shock or similar stress.Also note that the cause of the reported issue is attributed to wear and tear.Please note that signs of fatigue or pre-damage, such as minute cracks, are often hard to spot.Based on the available information reported, the potential cause of the no dvi image displayed can be attributed to the wrong type of interface used.In general the customer is required to check the function of all devices used prior to a procedure and a suitable replacement device must be provided during an application.As stated on the ifu (instructions for use manual) and as a preventative measure, the ifu states, 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.In the case of unclear remains of fracture fragments, of the insulating insert made of ceramic, these can be localized with a suitable x-ray procedure or computer tomography and removed, if necessary.Olympus will continue to monitor complaints for this device.

Manufacturer Narrative

This supplemental report was submitted to provide the investigation results from the legal manufacturer.The legal manufacturer performed a review of the device history records for the concerned device and no abnormalities were found.The product was sold in (b)(6) 2020.A review of the repair history indicates the device was not repaired in the past year.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.The legal manufacture could not conclusively determine the root cause of the reported event.However, based on the manufacturer¿s analysis, the likely cause of the event is due to damage of the insulation material of the sheath was caused by thermal mechanical overload, improper handling, mechanical impact like fall, shock or similar stress.However, 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.In the case of unclear remains of fracture fragments, of the insulating insert made of ceramic, these can be localized with a suitable x-ray procedure or computer tomography and removed, if necessary.In general the customer is required to check the function of all devices used prior to a procedure as stated on the ifu (instructions for use manual) and as a preventative measure, the ifu provides the following warnings: 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.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).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.Olympus will continue to monitor complaints for this device.

Manufacturer Narrative

This supplemental report was submitted to provide device evaluation results and a correction to the product receipt date (d9).The physical evaluation found the following: 1.Broken insulation tip.2.Slight dent in insertion tube.When inspecting the equipment, the broken insulation tip was observed.In the insertion tube, an indentation in the middle part was noted but is not related to the problem reported.The investigation is ongoing; therefore, the root cause of the reported issue cannot be determined at this time.However, if additional information becomes available a follow up medical device report will be supplemented accordingly.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH, WITH A22085A
• Type of Device: INNER SHEATH
• 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: 13467676
• MDR Text Key: 294652186
• Report Number: 9610773-2022-00072
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761029360
• UDI-Public: 04042761029360
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K931994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2022

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: A22040T
• Device Catalogue Number: A22040T
• Device Lot Number: 20501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/07/2022
• Initial Date FDA Received: 02/06/2022
• Supplement Dates Manufacturer Received: 02/11/2022; 03/01/2022
• Supplement Dates FDA Received: 02/22/2022; 03/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2020
• 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