MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS; RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS

Model Number A42011A

Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/19/2020

Event Type  Injury  

Manufacturer Narrative

The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient's outcome and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.

Event Description

Olympus was informed that during an unspecified hysteroscopy procedure, the ceramic insulation at the distal end of the resection sheath broke off inside the uterus.The surgeon managed to retrieve the broken fragment but the procedure was prolonged by 2 hours as a result.An x-ray examination is planned to verify no further fragments remained inside the patient.No further information was provided.

Manufacturer Narrative

Device evaluation: the suspect medical device was returned to the manufacturer for evaluation/investigation.The evaluation/investigation confirmed that the ceramic insulation at the distal end of the resection sheath is broken off and missing.The tip of the insulation insert was not provided for investigation.There are signs of corrosion and hairline cracks visible on the seating of the yellow sealing.Also, the laser labelling is severely worn.This type of damage is typically caused by thermal and/or mechanical overload as a result of incorrect reprocessing methods and/or wear and tear.Therefore, this event/incident was attributed to use error.It cannot be conclusively determined whether the insulating insert was pre-damaged at some point in the past, whether the damage was caused during the reprocessing cycle preceding the incident, or during the actual procedure.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the resection sheath without showing any abnormalities.The case will be closed from olympus side but, independently from the above-mentioned issue, a capa was initiated in (b)(6) 2019 where further investigations, trending, and surveillance will be performed.Furthermore, the user will be informed about the investigation results.

Event Description

Olympus was informed that during a therapeutic hysteroscopic resection procedure, the ceramic insulation at the distal end of the resection sheath broke off inside the uterus.The surgeon managed to retrieve the broken fragment but the procedure was prolonged by 2 hours as a result.An x-ray examination is planned to verify no further fragments remained inside the patient.No further information was provided.

• Brand Name: RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS
• Type of Device: RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 10875625
• MDR Text Key: 217449198
• Report Number: 9610773-2020-00274
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761023658
• UDI-Public: 04042761023658
• Combination Product (y/n): N
• PMA/PMN Number: K931994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A42011A
• Device Catalogue Number: A42011A
• Device Lot Number: 179W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 12/18/2020
• Supplement Dates FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention