MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS

Model Number A42011A

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to service center for an evaluation.A visual inspection was performed on the returned device and found the ceramic insulation at the distal end of the resection sheath broken off into multiple pieces.An attempted to reconstruct the ceramic tip by using adhesive to temporarily bond the broken piece(s) of the ceramic tip to the distal end of the resection sheath was performed.Approximately 20 percent of the insulation tip was still missing from the device and not returned for an evaluation.Further findings, include indentations on the sheath, and fading of the olympus logo, lot number and model name.Per the instructions for use: "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." based on the evaluation, the likely cause of the broken ceramic insulation tip is due to mishandling.

Event Description

The service center was informed that during a hysteroscopy procedure the inner sheath beak broke off and fell into the patient.The broken pieces were retrieved using a grasper.The intended procedure was completed using a similar device.There was no patient injury reported.In addition, it was reported that there is no sparking or arcing noted and device was inspected before use.

• Brand Name: RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS
• 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: 8961449
• MDR Text Key: 198132858
• Report Number: 9610773-2019-00117
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761023658
• UDI-Public: 04042761023658
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/04/2019

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: Health Professional
• Device Model Number: A42011A
• Device Catalogue Number: A42011A
• Device Lot Number: 154W-0027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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