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

Model Number A22040A

Device Problems Material Discolored (1170); Fluid/Blood Leak (1250); Scratched Material (3020)

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

Event Type  malfunction  

Manufacturer Narrative

Additional pma/510(k) number k931995.The device was returned to olympus.During their inspection, it was found that the seal rubber was discolored, a leak was observed, and the inside of the tip was scraped.The shaft had a leakage due to damaged sealing ring.Based on the present damage pattern, it is likely that the insulation tip's fracture was caused by thermal and mechanical induced impact.A manufacturing and quality control review was performed for the affected serial number without showing any non-conformities or deviations regarding the described issues.¿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.Inspection and testing: inspecting the product: visually inspect the product.Make sure that it has: no corrosion, no dents and 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.¿ olympus will continue to monitor the field performance of this device.

Event Description

It was reported to olympus that an inner sheath was sent in for repair.Seal rubber discoloration was found.The reported issue was found during estimation of the device.There was no injury or health damage due to the reported event.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: HYSTEROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16423517
• MDR Text Key: 310337544
• Report Number: 9610773-2023-00557
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761029339
• UDI-Public: 04042761029339
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K931994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/22/2023

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: Other
• Device Model Number: A22040A
• Device Catalogue Number: A22040A
• Device Lot Number: 188W--0064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2023
• Initial Date FDA Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2018
• 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