MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, STRYKERFLOW ELECTROCAUTERY PROBE, L TIP, 5MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number 0250070443

Device Problem Device Packaging Compromised (2916)

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

Event Date 02/01/2018

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 insulation was compromised.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: during procedure, it was noticed the hook and sheath had some thermal damage causing arching.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes for the melted sheath could be the electrocautery probe was not in contact with tissue; the electrocautery probe is activated while there is irrigation fluid in the sheath; or the tip is retracted into the sheath while the current is activated.The device manufacturer date is not known.Gtin: (b)(4).

Event Description

It was reported that the insulation was compromised.

• Brand Name: PKG, STRYKERFLOW ELECTROCAUTERY PROBE, L TIP, 5MM
• 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: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7304984
• MDR Text Key: 101278871
• Report Number: 0002936485-2018-00197
• 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: Initial,Followup
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• 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: 16H5204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2018
• 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