MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE SERFAS ENERGY SUPER 90-S; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 0279351300

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590); Detachment of Device or Device Component (2907)

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

Event Date 12/01/2014

Event Type  Injury  

Event Description

It was reported that during a knee arthroscopy procedure, the entire tip has allegedly broken off the serfas probe.The theatre staff noticed that the tip of the probe was missing after the procedure had been completed and they were undertaking a check on equipment used during the procedure.It was further reported that a scope was used in an attempt to locate the tip.Surgeon was unable to locate the tip and is unsure whether this is still inside the patient.

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Manufacturer Narrative

The tip breaking condition (electrode) was confirmed only on one (1) of the returned units.The detached piece (electrode) was not returned with the unit.The probable root causes for the reported condition can be associated, but are not limited to: non-conforming component.According to the device history record review, the lot was manufactured according to specifications.Poor assembly process: in addition, a 30x inspection of the probe¿s tip assembly is performed on all the probes during manufacturing.The activation history could not be retrieved since the affected unit was returned with the communication cable cut.The activation history is stored in the e-prom chip located inside the connector of the communication cable, which was not returned for evaluation.However, according to the returned unit¿s visual inspection it is evident that the condition was observed after use during surgery.Misuse: the probe is delivered inside a blister in which the unit is snapped in place, and the blister is placed inside a box, which provides protection to the tip of the probe.In the event that the probe is delivered to the customer with a damaged tip, then the unit must be discarded before use.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 during a knee arthroscopy procedure the entire tip has allegedly broken off the serfas probe.The theatre staff noticed that the tip of the probe was missing after the procedure had been completed and they were undertaking a check on equipment used during the procedure.It was further reported that a scope was used in an attempt to locate the tip.Surgeon was unable to locate the tip and is unsure whether this is still inside the patient.

• Brand Name: SERFAS ENERGY SUPER 90-S
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: thomas shafer ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 4303177
• MDR Text Key: 5269344
• Report Number: 0002936485-2014-00985
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K071859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0279351300
• Device Lot Number: 14211AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1