MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG,STRYKEFLOW ELECROCAUTERY PROBE, SPATULA TIP, 5MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0250070441
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2019
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was alleged that the spatula was slightly covered by the sheath causing the device to arc.The procedure was completed successfully.
Additional Manufacturer Narrative
Alleged failure: i have a few surgeons that use our strykeprobe electrosurgical suction tips for all of their gallbladders.They have told me recently that the inner sheath for the spatula 250-070-441 doesn¿t extend all the way out from the sheath like they used to.I looked through them today and confirmed.They are all the same part numbers but the spatula on a more recently purchased set is about a cm shorter than the other.The spatula is still slightly covered by the sheath.This has caused the spatula to arc to the sheath and put electricity in places that the surgeon does not intend.It also makes the sheaths need to be replaced sooner.Do you know if there has been a change in manufacturing with these? i have attached a couple of pics of the inserts.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be the burn is caused by activation of electrocautery with an extended sheath or a bent shaft causes the sheath to sit against the yellow heat shrink when the sheath is retracted.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.Gtin:07613327051865.
Event or Problem Description
It was alleged that the spatula was slightly covered by the sheath causing the device to arc.The procedure was completed successfully.

• Brand Name: PKG,STRYKEFLOW ELECROCAUTERY PROBE, SPATULA TIP, 5MM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8921054
• Report Number: 0002936485-2019-00355
• Device Sequence Number: 19365140
• Product Code: GCJ
• UDI-Device Identifier: 07613327051865
• UDI-Public: 07613327051865
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K934094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0250070441
• Device Lot Number: 18J5184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1