MAUDE Adverse Event Report: RICHARD WOLF GMBH PRINCESS; INNER SHEATH RESECTOSCOPE REUSABLE

Model Number 8653018

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

Rwmic will reach out to the user facility and the manufacturer to gather additional information.Upon receipt of the additional information, a follow up report will be submitted.

Event Description

On february 3rd, 2020, the initial reporter reach out to rwmic and reported that during a procedure the plastic tip broke inside the patient.Will the device be returned? yes.Was the device being used during a procedure when the issue occurred? yes.Was there any injury or illness to patient or other personnel due to issue? no.Did the issue cause a delay in the procedure being performed that put the patient at risk? no.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Labeling review ( ga-d349, bb - d349).Caution! the products have only limited strength! excessive force will cause damage, impair the function and therefore endanger the patient.Immediately before and after each use, check the products for damage, loose parts and completeness.Make sure that no missing parts remain in the patient.Do not use the products if they are damaged or incomplete or have loose parts.Caution! extended time in the operating room and reduced user comfort may result from incorrect size of the auxiliary instrument or blocked insertion channel! before use, make sure that the auxiliary instrument can be inserted easily and without resistance.Do not use auxiliary instruments that are difficult to introduce because they can become damaged during insertion.Insert only auxiliary instruments up to max.7 fr.Caution! careful if hf output power is incorrectly selected! injuries to the patient as well as damage to the product are possible.The power should be set on the basis of the surgeon's experience and training with regard to the corresponding indication.Rwmic considers this mor/complaint open.Rwmic will contact the user facility for missing patient information.

Event Description

Rwmic device evaluation 03/18/2020: findings, it was identified that the tip must had a crack and it broke off during procedure.The condition reported by the user facility is confirmed.Product disposition is repair.Possible root cause is user error.

Manufacturer Narrative

Richard wolf medical instruments (mic) is submitting this report on behalf of richard wolf gmbh.Mic is the importer of this device.No new information (other than this narrative(h10), and b4 and g6) being provided.This report is to close this mdr.User facility was contacted three times in an effort to collect patient information and user information.As of 3/17/2021, rwmic has not received a response.Rwgmbh considers this case closed.Should additional information become available a follow up report will be submitted.

• Brand Name: PRINCESS
• Type of Device: INNER SHEATH RESECTOSCOPE REUSABLE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10307623
• MDR Text Key: 199914769
• Report Number: 1418479-2020-00006
• Device Sequence Number: 1
• Product Code: FDC
• UDI-Device Identifier: 04055207042861
• UDI-Public: 04055207042861
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2020,03/19/2021

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: No Information
• Device Model Number: 8653018
• Device Catalogue Number: 8653.018
• Device Lot Number: 1333560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2020
• Distributor Facility Aware Date: 02/03/2020
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2020
• Initial Date Manufacturer Received: 07/22/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 07/22/2020; 07/22/2020
• Supplement Dates FDA Received: 10/12/2020; 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1