MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OUTER SHEATH, 8.5 MM / 26 FR., 2 STOPCOCKS, ROTATABLE; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 20214A OLYMPUS

Device Problems Component Missing (2306); Structural Problem (2506); Sharp Edges (4013)

Patient Problem Perforation (2001)

Event Date 05/17/2023

Event Type  malfunction  

Event Description

Olympus cysto resection instrument (b)(6) double barrelled seath has missing piece leaving the instrument sharp which caused perforation to sterile glove.Per doctor this has been an issue previously as well and he is requesting a repair.

• Brand Name: OUTER SHEATH, 8.5 MM / 26 FR., 2 STOPCOCKS, ROTATABLE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; 800 west park drive; westborough MA 01581
• MDR Report Key: 17342070
• MDR Text Key: 319202962
• Report Number: 17342070
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/06/2023,05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 20214A OLYMPUS
• Device Catalogue Number: 20214A OLYMPUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2023
• Date Report to Manufacturer: 07/18/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29565 DA