MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE BIOPSY CUP 5FR SEMI FLEX; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number 0502555400

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 06/24/2014

Event Type  malfunction  

Event Description

It was reported that the device became detached.

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Manufacturer Narrative

The following repair diagnostic codes were identified: (1) rust on handle.The following service codes were identified: (1) swap laparoscopic instrument.This does confirm the alleged failure mode of detached/ broken device.Probable root cause: 1.User excessive force or torque; 2.Manufacturing/assembly error; 3.Severe shipping conditions; 4.User error in not properly inspecting unit prior to use; 5.Material/design error; 6.Constant irrigation flow is not maintained leading to limited field of view; 7.Low lubricity of instrument shaft; 8.Use of incompatible instrumentation/hardware; 9.Corrosion or rusting; 10.Improper cleaning/sterilization.In sum, the unit was returned and the failure mode was confirmed.

Event Description

It was reported that the device became detached.

• Brand Name: BIOPSY CUP 5FR SEMI FLEX
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: thomas shafer ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 3946136
• MDR Text Key: 4604079
• Report Number: 0002936485-2014-00512
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/24/2014

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: Other
• Device Catalogue Number: 0502555400
• Device Lot Number: 1342773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/24/2014
• Initial Date FDA Received: 07/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/08/2014
• 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