MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 26 FR.

Model Number A22042A

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/26/2021

Event Type  malfunction  

Event Description

Olympus received a medwatch report (#3902560000-2021-8117) via email which states, "during transurethral resection of the prostate (turp), per dr, the white tip of the inner sheath of the 28 french resectoscope came off in the patient's bladder.The entire tip was retrieved out of the patient by dr2, per dr1.The tip and the resectoscope inner sheath were removed from the sterile field and taken out of service.Unfortunately, item was discarded." no death, injury or infection was reported to olympus.

Manufacturer Narrative

The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available a follow up medical device report will be supplemented accordingly.

Event Description

The patient safety specialist at the user facility provided the response via email from the physician which states, ¿we noted that insulating beak of the inner sheath of the resectoscope had broken off and was in the bladder in the dependent position.We were unable to retrieve this beak using the loop of the resectoscope; we therefore removed the resectoscope, passed a rigid cystoscope and passed flexible graspers, grasped the beak, and removed the beak intact.We then inspected the inner sheath and the broken beak and it appeared to have sheared off flush at the tip of the inner resectoscope sheath and that there were no other pieces." the patient safety specialist further reported the procedure was completed successfully.No serious delay or patient harm as we recognized the broken piece and retrieved it successfully.The beak was intact at the beginning of the case or else the fragment would not have been found in the bladder.At the end of use, the resectoscopes are routinely cleaned and sent for reprocessing so it can be available for surgery.

Manufacturer Narrative

This supplemental report was submitted to provide additional details regarding the event.(b5).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The dhr was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The case is not due to design.Based on the results of the investigation, it is likely 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.Additionally, a white ceramic tip means that it is either a device manufactured before 2010 or that a third-party repair/intervention took place.A definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): "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 centre." olympus will continue to monitor the field performance of this device.

• Brand Name: RESECTION SHEATH, 26 FR.
• Type of Device: RESECTION 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: 13014916
• MDR Text Key: 290287154
• Report Number: 9610773-2021-00357
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020985
• UDI-Public: 04042761020985
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22042A
• Device Catalogue Number: A22042A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 68 YR
• Patient Sex: Male