MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, RESECTOSCOPE CABLE, (VALLEYLAB/BOVIE); CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Catalog Number 0502990300

Device Problem Split (2537)

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

Event Date 11/09/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the cord split into two pieces and had a burned connection.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: the piece that connect to laparoscopic instrument burned off.Surgeon felt it hotter, the cord split into two separate pieces.Did not hurt patient or cause fire.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: power set too high, generator power malfunction, improper sterilization methods, or improper drying the reported failure mode will be monitored for future reoccurrence.(b)(4).

Event Description

It was reported that the cord split into two pieces and had a burned connection.

• Brand Name: PKG, RESECTOSCOPE CABLE, (VALLEYLAB/BOVIE)
• Type of Device: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• 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: victoria milich ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 6153486
• MDR Text Key: 62141203
• Report Number: 0002936485-2016-01144
• Device Sequence Number: 1
• Product Code: FAJ
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0502990300
• Device Lot Number: 1090782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2008
• 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