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

Model Number A22041A

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

Patient Problem Hemorrhage/Bleeding (1888)

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 therapeutic procedure at an unknown date, the ceramic insulation at the distal end of the inner sheath broke off and fell into the patient's body cavity.The broken off fragment could be retrieved successfully, but the intended procedure was prolonged by about one hour.The patient also reportedly lost more blood than usual during the procedure.No further information was provided.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the customer¿s complaint was confirmed.The evaluation findings are as follows: the ceramic tip of the sheath is broken off.Additionally, the following non-reportable findings were noted: rust and stress cracks on the sheath, damaged yellow sealing ring and faded laser marking.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, although the root cause could not be determined, the event was likely caused by the following: thermo-mechanical fatigue, wear, and tear, and/or improper handling (impact, shock).The event can be detected/prevented by following the instructions for use (ifu) which state: ¿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.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.¿ this supplemental report includes a correction to the following fields: a1, d4, e1, e3, and g2.H6 code - health impact was corrected from "4633" to "4632" from initial medwatch.New information has been added to d8 and d9.Also, an update has been made to h3.Olympus will continue to monitor field performance for this device.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 16589169
• MDR Text Key: 311737897
• Report Number: 9610773-2023-00839
• Device Sequence Number: 1
• Product Code: FJL
• UDI-Device Identifier: 04042761020961
• UDI-Public: 04042761020961
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K931995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

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: A22041A
• Device Catalogue Number: A22040A
• Device Lot Number: 192W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 03/22/2023
• Supplement Dates Manufacturer Received: 04/13/2023
• Supplement Dates FDA Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2019
• 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 Outcome(s): Required Intervention