MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE AUTOCLAVABLE HAND CONTROL; ARTHROSCOPE

Catalog Number 0350220000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 09/08/2016

Event Type  malfunction  

Manufacturer Narrative

The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.(b)(4).

Event Description

It was reported that the pump remote control shoots at the highest pressure automatically.There was no patient involvement and therefore no adverse consequence.

Manufacturer Narrative

Alleged failure: automatic button function.The failure(s) identified in the investigation is consistent with the complaint record.Probable root causes could be normal wear and tear, exceeded, unwanted movement of internal wiring.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.(b)(4).

Event Description

It was reported that the pump remote control shoots at the highest pressure automatically.There was no patient involvement and therefore no adverse consequence.

• Brand Name: AUTOCLAVABLE HAND CONTROL
• Type of Device: ARTHROSCOPE
• 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: kimberly lynch ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 5996106
• MDR Text Key: 56801017
• Report Number: 0002936485-2016-00929
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/13/2017

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 Catalogue Number: 0350220000
• Device Lot Number: 1317691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2016
• Initial Date FDA Received: 10/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/13/2017
• 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