MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4130, 5MMX35CM EPIX LAPA GRASPER, 10/BX; NWV

Model Number 1

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

Applied medical has just received the event device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.

Event Description

Procedure performed: lap hysterectomy.Event description: the issue occurred minutes within opening and using the product.The grasper was placed down a port, and whilst the surgeon was moving it, the hinged area actually caught itself on a piece of bowel, which had to be separated using another instrument as it would not be let go even with manipulation of the grasper.We opened another grasper which appeared to work fine for the duration of the procedure but of course it was not an ideal situation, however luckily no bowel damage was done.Any help with this matter would be gratefully appreciated.Additional information received from applied team member, august 04, 2017: incident occured when using grasper for first time in the case.Grasper was placed down a port and whilst the surgeon was moving it, the hinged area caught on a piece of bowel.The surgeon attempted to free the grasper by opening and closing jaws which did not work.Eventually the grasper was separated from the bowel by by prising it with another instrument.A second epix lap grasper was opened and used with no issues for the remainder of the case.Type of intervention: n/a.Patient status: "did a patient injury or illness occur associated with the complaint event? no".

Manufacturer Narrative

Investigation summary: the event unit was returned to applied medical for evaluation.A visual inspection and component evaluation was performed on the event unit.However, the complainant's experience could not be replicated or confirmed.The event unit met current specifications and there were no visible non-conformances.Based on the condition of the returned unit and the additional information received from the complainant, it is likely that the reported event was caused by the manner in which the unit was maneuvered after insertion.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

• Brand Name: C4130, 5MMX35CM EPIX LAPA GRASPER, 10/BX
• Type of Device: NWV
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: wendy kobayashi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138059
• MDR Report Key: 6832810
• MDR Text Key: 84094278
• Report Number: 2027111-2017-01992
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915110147
• UDI-Public: (01)00607915110147(17)200222(30)01(10)1290550
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: 1
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/05/2017

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
• Device Operator: Other
• Device Expiration Date: 02/22/2020
• Device Model Number: 1
• Device Catalogue Number: 1
• Device Lot Number: 1290550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/02/2017
• Initial Date FDA Received: 08/30/2017
• Supplement Dates Manufacturer Received: 08/02/2017
• Supplement Dates FDA Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1