MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 5MM X 32CM STRYKEPROBE L-TIP; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number 0250070443

Device Problems Thermal Decomposition of Device (1071); Fitting Problem (2183)

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

Event Date 08/18/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the probe burned through the sheaths and the l tip probe did not fit the sheath.

Manufacturer Narrative

The probe was visually inspected for damages, and the yellow sheath on the distal end is cracked.Also, the inside of the 90 degree bend of the l-tip has damage.The l-tip is not the correct diameter, and appears to have been replaced.There is evidence of third party repair to the l-tip.The l-tip has been welded back on to the probe using a different method other than laser weld.Unable to function test the probe due to the replaced l-tip being bigger than original, and not fitting into the sheath.The probable root causes could be third party repair.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the probe burned through the sheaths and the l tip probe did not fit the sheath.

• Brand Name: 5MM X 32CM STRYKEPROBE L-TIP
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 5073080
• MDR Text Key: 26080057
• Report Number: 0002936485-2015-00822
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0250070443
• Device Lot Number: 12E0420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/19/2015
• 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